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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00801255




Registration number
NCT00801255
Ethics application status
Date submitted
2/12/2008
Date registered
3/12/2008
Date last updated
2/11/2016

Titles & IDs
Public title
A Study of Combination Treatment With an HCV Polymerase Inhibitor (RO5024048) and an HCV Protease Inhibitor (RO5190591/Danoprevir) in Genotype 1 Chronic Hepatitis C Patients
Scientific title
A Randomized, Placebo-controlled, Dose-ranging Study to Evaluate the Safety, Tolerability and Antiviral Activity of Combination Treatment With an HCV Polymerase Inhibitor (RO5024048) and an HCV Protease Inhibitor (RO5190591) in Genotype 1 Chronic Hepatitis C Patients. INFORM 1
Secondary ID [1] 0 0
PP22205
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C, Chronic 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RO5024048
Treatment: Drugs - danoprevir
Treatment: Drugs - danoprevir
Treatment: Drugs - danoprevir
Treatment: Drugs - danoprevir
Treatment: Drugs - danoprevir

Experimental: Cohort A -

Experimental: Cohort B -

Experimental: Cohort C -

Experimental: Cohort D -

Experimental: Cohort E -

Experimental: Cohort F -

Experimental: Cohort G -


Treatment: Drugs: RO5024048
500mg po bid/100mg po q8h for 7 days

Treatment: Drugs: danoprevir
500mg po bid/100mg po q8h for 14 days

Treatment: Drugs: danoprevir
1000mg po bid/100mg po q8h for 14 days\\n500mg po bid/200mg po q8h for 14 days

Treatment: Drugs: danoprevir
1000mg po bid/200mg po q8h for 14 days

Treatment: Drugs: danoprevir
1000mg/600mg po twice daily for 14 days

Treatment: Drugs: danoprevir
1000mg/900mg po twice daily for 14 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
HCV RNA
Timepoint [1] 0 0
At each clinic visit, throughout study
Primary outcome [2] 0 0
Adverse events, laboratory parameters, vital signs
Timepoint [2] 0 0
At each clinic visit, throughout study
Secondary outcome [1] 0 0
PK parameters;viral resistance
Timepoint [1] 0 0
At intervals, throughout study

Eligibility
Key inclusion criteria
* adult patients, 18-65 years of age;
* chronic hepatitis C, genotype 1.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* decompensated liver disease, or impaired liver function;
* presence or history of non-hepatitis C chronic liver disease;
* HBsAg or HIV infection;
* history of cancer within 5 years, other than localized or in situ cancer of the skin.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2010
Sample size
Target
Accrual to date
Final
88
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Heidelberg
Recruitment hospital [3] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
SA 5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
3181 - Melbourne
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch
Country [2] 0 0
New Zealand
State/province [2] 0 0
Grafton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00801255