Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01281839
Registration number
NCT01281839
Ethics application status
Date submitted
7/01/2011
Date registered
24/01/2011
Date last updated
23/04/2014
Titles & IDs
Public title
An Efficacy, Safety and Tolerability Study of TMC435 in Genotype 1 Hepatitis C-infected Patients Who Relapsed After Previous Therapy
Query!
Scientific title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of TMC435 vs Placebo as Part of a Treatment Regimen Including Peginterferon a-2a and Ribavirin in Hepatitis C, Genotype 1 Infected Subjects Who Relapsed After Previous Interferon-based Therapy
Query!
Secondary ID [1]
0
0
TMC435HPC3007
Query!
Secondary ID [2]
0
0
CR017371
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
PROMISE
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Hepatitis C
0
0
Query!
Condition category
Condition code
Infection
0
0
0
0
Query!
Other infectious diseases
Query!
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - TMC435
Treatment: Drugs - Placebo
Treatment: Drugs - Peginterferon alpha-2a (PegIFN alpha-2a)
Treatment: Drugs - Ribavirin (RBV)
Experimental: TMC435 - TMC435 150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a and ribavirin for 24 or 48 weeks
Placebo Comparator: Placebo - Placebo 150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a and ribavirin for 48 weeks
Treatment: Drugs: TMC435
150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a and ribavirin for 24 or 48 weeks
Treatment: Drugs: Placebo
150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a and ribavirin for 48 weeks
Treatment: Drugs: Peginterferon alpha-2a (PegIFN alpha-2a)
One subcutaneous (under the skin) injection containing 0.5 mL solution with 180 mcg PegIFN alpha-2a once weekly for up to 48 weeks.
Treatment: Drugs: Ribavirin (RBV)
200-mg tablets of RBV (body-weight adjusted dose) taken orally (by mouth) twice daily for up to 48 weeks.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)
Query!
Assessment method [1]
0
0
The table below shows the percentage of participants in each treatment group who achieved a SVR12, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid 12 weeks after planned end of treatment.
Query!
Timepoint [1]
0
0
Week 36 or Week 60
Query!
Secondary outcome [1]
0
0
The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)
Query!
Assessment method [1]
0
0
The table below shows the percentage of participants in each treatment group who achieved a SVRW72, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72.
Query!
Timepoint [1]
0
0
Week 72
Query!
Secondary outcome [2]
0
0
The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)
Query!
Assessment method [2]
0
0
The table below shows the percentage of participants in each treatment group who achieved a SVR24, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 24 weeks after planned end of treatment.
Query!
Timepoint [2]
0
0
Week 48 or Week 72
Query!
Secondary outcome [3]
0
0
The Percentage of Participants Who Achieved a Sustained Virologic Response 4 Weeks After the Planned End of Treatment (SVR4)
Query!
Assessment method [3]
0
0
The table below shows the percentage of participants in each treatment group who achieved a SVR4, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 4 weeks after planned end of treatment.
Query!
Timepoint [3]
0
0
Week 28 or Week 52
Query!
Secondary outcome [4]
0
0
Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
Query!
Assessment method [4]
0
0
The table below shows change from baseline in log10 HCV RNA levels.
Query!
Timepoint [4]
0
0
Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48
Query!
Secondary outcome [5]
0
0
Actual Values of log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
Query!
Assessment method [5]
0
0
The table below shows actual values of log10 HCV RNA levels. From Week 4 onwards, most participants in TMC 435 150mg 12Wks PR24/48 group had plasma HCV RNA levels below the limit of detection of the HCV RNA assay.
Query!
Timepoint [5]
0
0
Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48
Query!
Secondary outcome [6]
0
0
The Percentage of Participants With On-treatment Virologic Response at All Time Points
Query!
Assessment method [6]
0
0
The table below shows the percentage of participants with HCV ribonucleic acid (RNA plasma levels below the limit of detection (ie, <25 IU/mL undetectable), the percentage of participants with a HCV RNA plasma level below the limit of quantification (ie, less than [<] 25 IU/mL detectable or undetectable), the percentage of participants with plasma levels of HCV RNA <100 IU/mL, the percentage of participants with virologic responses of a greater than or equal to 2 log10 change from baseline in plasma levels of HCV RNA.
Query!
Timepoint [6]
0
0
Day 3, Week 1, Week 2, Week 8, Week 16, Week 20, Week 28, Week 36, and Week 42
Query!
Secondary outcome [7]
0
0
The Percentage of Participants Achieving a Rapid Virologic Response (RVR)
Query!
Assessment method [7]
0
0
The table below shows the percentage of participants in each treatment group who achieved a RVR, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels after receiving 4 weeks of treatment.
Query!
Timepoint [7]
0
0
Week 4
Query!
Secondary outcome [8]
0
0
The Percentage of Participants Achieving a Early Virologic Response (EVR)
Query!
Assessment method [8]
0
0
The table below shows the percentage of participants who achieved an EVR, defined as having a change from baseline in plasma Hepatitis C virus ribonucleic acid of greater than or equal to 2 log10 at Week 12.
Query!
Timepoint [8]
0
0
Week 12
Query!
Secondary outcome [9]
0
0
The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)
Query!
Assessment method [9]
0
0
The table below shows the percentage of participants in each treatment group who had a cEVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 12.
Query!
Timepoint [9]
0
0
Week 12
Query!
Secondary outcome [10]
0
0
The Percentage of Participants Achieving a Extended Rapid Virologic Response (eRVR)
Query!
Assessment method [10]
0
0
The table below shows the percentage of participants in each treatment group who had a eRVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 4 and 12.
Query!
Timepoint [10]
0
0
Week 4 and Week 12
Query!
Secondary outcome [11]
0
0
The Percentage of Participants With <1 log10 Decrease in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Week 4
Query!
Assessment method [11]
0
0
The table below shows the percentage of participants in each treatment group with <1 log10 HCV RNA decrease at Week 4.
Query!
Timepoint [11]
0
0
Week 4
Query!
Secondary outcome [12]
0
0
Percentage of Participants With in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels >1000 IU/mL at Week 4
Query!
Assessment method [12]
0
0
The table below shows the percentage of participants in each treatment group with HCV RNA levels >1000 IU/mL at Week 4.
Query!
Timepoint [12]
0
0
Week 4
Query!
Secondary outcome [13]
0
0
The Percentage of Participants With Null Response
Query!
Assessment method [13]
0
0
The table below shows the percentage of participants with null response, defined as <2 log10 reduction in Hepatitis C virus ribonucleic acid at Week 12 compared to baseline.
Query!
Timepoint [13]
0
0
Week 12
Query!
Secondary outcome [14]
0
0
The Percentage of Participants With Partial Response
Query!
Assessment method [14]
0
0
The table below shows the percentage of participants with partial response, defined as =>2 log10 reduction in Hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 compared to baseline, but not achieving undetectable HCV RNA while on treatment.
Query!
Timepoint [14]
0
0
Week 12
Query!
Secondary outcome [15]
0
0
The Percentage of Participants With Viral Breakthrough
Query!
Assessment method [15]
0
0
The table below shows the percentage of participants with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable).
Query!
Timepoint [15]
0
0
Up to Week 48
Query!
Secondary outcome [16]
0
0
The Percentage of Participants With Viral Relapse
Query!
Assessment method [16]
0
0
The table below shows the percentage of participants with viral relapse, defined as having confirmed detectable plasma level of Hepatitis C virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment.
Query!
Timepoint [16]
0
0
Up to Week 72
Query!
Secondary outcome [17]
0
0
The Percentage of Participants Who Completed All Study Treatment at Week 24 Because of the Treatment Duration Rule
Query!
Assessment method [17]
0
0
The table below shows the percentage of participants in the TMC435 treatment group who met the treatment duration rule (ie, having hepatitis C virus [HCV] ribonucleic acid [RNA] levels <25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA levels at Week 12) and completed treatment with PegIFNa-2a and RBV for 24 weeks. Participants in the TMC435 treatment group not meeting RGT criteria and participants in the placebo group were treated with PegIFNa-2a and RBV treatment for 48 weeks.
Query!
Timepoint [17]
0
0
Week 24
Query!
Secondary outcome [18]
0
0
The Percentage of Participants With On-treatment Failure
Query!
Assessment method [18]
0
0
The table below shows percentage of participants with on-treatment failure defined as confirmed detectable Hepatitis C virus ribonucleic acid levels at actual end of treatment.
Query!
Timepoint [18]
0
0
Week 48
Query!
Secondary outcome [19]
0
0
Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable
Query!
Assessment method [19]
0
0
The table below shows mean time in days to reach HCV RNA levels <25 IU/mL undetectable or detectable.
Query!
Timepoint [19]
0
0
Up to Week 48
Query!
Secondary outcome [20]
0
0
Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable or Detectable
Query!
Assessment method [20]
0
0
The table below shows mean time in days to reach HCV RNA levels <25 IU/mL undetectable or detectable.
Query!
Timepoint [20]
0
0
Up to Week 48
Query!
Secondary outcome [21]
0
0
Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <100 IU/mL
Query!
Assessment method [21]
0
0
The table below shows mean time in days to reach HCV RNA levels <100 IU/mL.
Query!
Timepoint [21]
0
0
Up to Week 48
Query!
Secondary outcome [22]
0
0
Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <1000 IU/mL
Query!
Assessment method [22]
0
0
The table below shows mean time in days to reach HCV RNA levels <1000 IU/mL.
Query!
Timepoint [22]
0
0
Up to Week 48
Query!
Secondary outcome [23]
0
0
The Percentage of Participants With Viral Breakthrough at Different Time Points
Query!
Assessment method [23]
0
0
The table below shows the percentage of participants at different time points with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma HCV ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable).
Query!
Timepoint [23]
0
0
Up to Week 48
Query!
Secondary outcome [24]
0
0
Time From End-of-treatment to Viral Relapse
Query!
Assessment method [24]
0
0
The table below shows the mean number of days to viral relapse, defined as participants having confirmed detectable plasma level of Hepatitis C Virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (<25 IU/mL undetectable) at the end of treatment.
Query!
Timepoint [24]
0
0
Up to Week 72
Query!
Secondary outcome [25]
0
0
The Percentage of Participants With Normalization of Alanine Aminotransferase (ALT)
Query!
Assessment method [25]
0
0
The percentage of participants analyzed were those with baseline ALT values out of the normal range (ie, 156 of 260 participants in the TMC435 treatment group and 84 of 133 participants in the Placebo group had ALT values at baseline that were out of the normal range.). Normalization of ALT values means that ALT values out of the normal range returned to within the normal range.
Query!
Timepoint [25]
0
0
Up to Week 48
Query!
Secondary outcome [26]
0
0
Median Time to Normalization of Alanine Aminotransferase (ALT) Levels
Query!
Assessment method [26]
0
0
The table below shows the median time to normalization of ALT levels.
Query!
Timepoint [26]
0
0
Up to Week 48
Query!
Secondary outcome [27]
0
0
Plasma Concentration of TMC435: Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)
Query!
Assessment method [27]
0
0
The table below shows mean (standard deviation) values of the area under the plasma concentration-time curve from time of administration to 24 hours (AUC 24hr) after dosing for TMC435. To calculate the mean AUC 24 for the study, AUC 24 hr values were derived for each participant at each visit and then the median of AUC value across visits for each participant was used to calculate the mean AUC 24 hr for the study.
Query!
Timepoint [27]
0
0
From the time of administration up to 24 hours after dosing through Week 12
Query!
Secondary outcome [28]
0
0
Plasma Concentration of TMC435: Predose Plasma Concentration (C0h)
Query!
Assessment method [28]
0
0
The table below shows mean (standard deviation) of C0h values of TMC435. To calculate the mean C0h for the study, C0h values were derived for each participant at each visit and then the median of C0h values across visits for each participant was used to calculate the mean C0h for the study.
Query!
Timepoint [28]
0
0
Before administration of TMC435 through Week 12
Query!
Secondary outcome [29]
0
0
Plasma Concentration of TMC435: Systemic Clearance (CL)
Query!
Assessment method [29]
0
0
The table below shows mean (standard deviation) of CL values of TMC435. To calculate the mean CL for the study, CL values were derived for each participant at each visit and then the median of CL values across visits for each participant was used to calculate the mean CL for the study.
Query!
Timepoint [29]
0
0
From the time of administration through Week 12
Query!
Eligibility
Key inclusion criteria
- Genotype 1 hepatitis C infection (confirmed at screening)
- Have previously received peginterferon-based therapy for at least 24 weeks with
documented HCV RNA at last measurement and relapsed within 1 year of last taking
medication
- Liver biopsy within 3 years before screening (or between the screening and baseline
visit) showing chronic hepatitis C infection
- Must agree to use 2 forms of effective contraception throughout study (both males and
females)
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Infection with HIV or non-genotype 1 hepatitis C
- Liver disease not related to hepatitic C infection
- Hepatic decompensation
- Significant laboratory abnormalities or other active diseases
- Pregnant or planning to become pregnant
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/02/2011
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/02/2013
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
394
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
- Adelaide
Query!
Recruitment hospital [2]
0
0
- Kingswood
Query!
Recruitment hospital [3]
0
0
- Melbourne
Query!
Recruitment hospital [4]
0
0
- Sydney
Query!
Recruitment hospital [5]
0
0
- Woolloongabba N/A
Query!
Recruitment postcode(s) [1]
0
0
- Adelaide
Query!
Recruitment postcode(s) [2]
0
0
- Kingswood
Query!
Recruitment postcode(s) [3]
0
0
- Melbourne
Query!
Recruitment postcode(s) [4]
0
0
- Sydney
Query!
Recruitment postcode(s) [5]
0
0
- Woolloongabba N/A
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Georgia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Kentucky
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Minnesota
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Mississippi
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Tennessee
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Texas
Query!
Country [10]
0
0
Austria
Query!
State/province [10]
0
0
Wien
Query!
Country [11]
0
0
Belgium
Query!
State/province [11]
0
0
Antwerpen
Query!
Country [12]
0
0
Belgium
Query!
State/province [12]
0
0
Brugge
Query!
Country [13]
0
0
Belgium
Query!
State/province [13]
0
0
Brussels
Query!
Country [14]
0
0
Belgium
Query!
State/province [14]
0
0
Brussel
Query!
Country [15]
0
0
Belgium
Query!
State/province [15]
0
0
Gent
Query!
Country [16]
0
0
Belgium
Query!
State/province [16]
0
0
Leuven
Query!
Country [17]
0
0
Canada
Query!
State/province [17]
0
0
British Columbia
Query!
Country [18]
0
0
Canada
Query!
State/province [18]
0
0
Ontario
Query!
Country [19]
0
0
Canada
Query!
State/province [19]
0
0
Quebec
Query!
Country [20]
0
0
France
Query!
State/province [20]
0
0
Creteil N/A
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Grenoble
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Lyon
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Nice N/A
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Paris Cedex 12
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Paris
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Rennes Cedex
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Vandoeuvre Les Nancy
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
Berlin
Query!
Country [29]
0
0
Germany
Query!
State/province [29]
0
0
Düsseldorf
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Frankfurt
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
Freiburg
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Halle (Saale)
Query!
Country [33]
0
0
Germany
Query!
State/province [33]
0
0
Hamburg
Query!
Country [34]
0
0
Germany
Query!
State/province [34]
0
0
Kiel
Query!
Country [35]
0
0
Germany
Query!
State/province [35]
0
0
Leipzig
Query!
Country [36]
0
0
Germany
Query!
State/province [36]
0
0
Munchen
Query!
Country [37]
0
0
Germany
Query!
State/province [37]
0
0
Würzburg
Query!
Country [38]
0
0
New Zealand
Query!
State/province [38]
0
0
Auckland
Query!
Country [39]
0
0
New Zealand
Query!
State/province [39]
0
0
Christchurch
Query!
Country [40]
0
0
New Zealand
Query!
State/province [40]
0
0
Hamilton
Query!
Country [41]
0
0
Poland
Query!
State/province [41]
0
0
Bialystok
Query!
Country [42]
0
0
Poland
Query!
State/province [42]
0
0
Bydgoszcz
Query!
Country [43]
0
0
Poland
Query!
State/province [43]
0
0
Czeladz
Query!
Country [44]
0
0
Poland
Query!
State/province [44]
0
0
Kielce
Query!
Country [45]
0
0
Poland
Query!
State/province [45]
0
0
Krakow
Query!
Country [46]
0
0
Poland
Query!
State/province [46]
0
0
Warszawa
Query!
Country [47]
0
0
Puerto Rico
Query!
State/province [47]
0
0
Ponce Pr
Query!
Country [48]
0
0
Puerto Rico
Query!
State/province [48]
0
0
San Juan
Query!
Country [49]
0
0
Russian Federation
Query!
State/province [49]
0
0
Moscow
Query!
Country [50]
0
0
Russian Federation
Query!
State/province [50]
0
0
Saint-Petersburg
Query!
Country [51]
0
0
Russian Federation
Query!
State/province [51]
0
0
Samara
Query!
Country [52]
0
0
Russian Federation
Query!
State/province [52]
0
0
Smolensk
Query!
Country [53]
0
0
Russian Federation
Query!
State/province [53]
0
0
St Petersburg
Query!
Country [54]
0
0
Russian Federation
Query!
State/province [54]
0
0
Stavropol
Query!
Country [55]
0
0
Spain
Query!
State/province [55]
0
0
Barcelona
Query!
Country [56]
0
0
Spain
Query!
State/province [56]
0
0
Madrid
Query!
Country [57]
0
0
Spain
Query!
State/province [57]
0
0
Sevilla N/A
Query!
Country [58]
0
0
Spain
Query!
State/province [58]
0
0
Valencia
Query!
Country [59]
0
0
United Kingdom
Query!
State/province [59]
0
0
Birmingham
Query!
Country [60]
0
0
United Kingdom
Query!
State/province [60]
0
0
Derby
Query!
Country [61]
0
0
United Kingdom
Query!
State/province [61]
0
0
Glasgow
Query!
Country [62]
0
0
United Kingdom
Query!
State/province [62]
0
0
London
Query!
Country [63]
0
0
United Kingdom
Query!
State/province [63]
0
0
Plymouth
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Janssen R&D Ireland
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to investigate the effectiveness and safety of TMC435 compared
with placebo in patients who are infected with genotype 1 hepatitis C virus who relapsed
after previous interferon-based therapy. Patients will also receive peginterferon alfa-2a and
ribavirin as part of their treatment.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01281839
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Janssen R&D Ireland Clinical Trial
Query!
Address
0
0
Janssen R&D Ireland
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01281839
Download to PDF