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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00983060




Registration number
NCT00983060
Ethics application status
Date submitted
22/09/2009
Date registered
23/09/2009
Date last updated
19/12/2020

Titles & IDs
Public title
Adaptive-design Dose Finding Study to Assess the Antiviral Efficacy and Safety of NIM811 Administered in Combination With Standard of Care (SOC) in Relapsed Hepatitis C Virus 1 (HCV-1) Infected Patients
Scientific title
A Randomized, Adaptive-design, Dose-finding Study to Assess the Antiviral Efficacy and Safety of NIM811 Administered in Combination With the Standard of Care (SOC) in Relapsed Patients Infected With HCV Genotype-1
Secondary ID [1] 0 0
EUDRACT number: 2009-009995-11
Secondary ID [2] 0 0
CNIM811B2202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis C Genotype-1 Relapse 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 - NIM811
Treatment: Drugs - Placebo BID + SOC

Experimental: NIM811 -

Placebo Comparator: Placebo -


Treatment: Drugs: NIM811
BID in various doses (between 100 mg - 600 mg bid) + SOC (PEG IFN and RBV)

Treatment: Drugs: Placebo BID + SOC
Placebo BID + SOC (PEG IFN and RBV)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the safety and tolerability of NIM811 dosed daily for 4 weeks in combination with SOC
Timepoint [1] 0 0
4 weeks
Secondary outcome [1] 0 0
To identify a dose of NIM811 which is safe and tolerated and produces in combination with SOC a clinically meaningful improvement over SOC monotherapy in antiviral response Time Frame: 4 weeks
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
To assess the percentage of patients achieving rapid virologic response (RVR) in patients treated with NIM811 in combination with SOC
Timepoint [2] 0 0
4 weeks
Secondary outcome [3] 0 0
To explore the pharmacokinetics and pharmacodynamics of NIM811 given in combination with SOC in patients with chronic hepatitis C genotype-1
Timepoint [3] 0 0
3 weeks, 5 weeks
Secondary outcome [4] 0 0
To evaluate the effect of NIM811 given in combination with SOC in patients with chronic hepatitis C genotype-1 on sustained virologic response 12 weeks after cessation of treatment (SVR12)
Timepoint [4] 0 0
12 weeks after cessation of treatment

Eligibility
Key inclusion criteria
Inclusion criteria:

Patients eligible for inclusion in this study have to fulfill all of the following
criteria:

- chronic hepatitis C genotype-1

- HCV-RNA should be = 4 x 105 IU/mL at screening

- Recipient of prior long acting interferon and ribavirin treatment for at least 12
weeks, with documented negative serum HCV RNA on treatment, who subsequently becomes
serum HCV RNA positive after stopping treatment ("relapser"). Patients must have been
off all treatment for at least 3 months prior to start of study (Visit
Minimum age
18 Years
Maximum age
69 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- Use of any HCV treatment = 3months prior to study start

- Prior receipt of any investigational anti-HCV therapy which is not IFN or RBV

- Women of child-bearing potential unless they are post-menopausal or use predefined
acceptable methods of contraception

- Pregnant or breastfeeding women

- Evidence of cirrhosis, hepatic decompensation, other than HCV liver disease, HBV or
HIV infection

- Specified abnormalities in lab values of amongst others hemoglobin, WBC, ANC,
platelets

- History of treatment for depression

- Steroid/immunosuppression drug use 3 months prior to study start Other
protocol-defined inclusion/exclusion criteria may apply

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 2
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
1/09/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
59
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Clayton
Recruitment hospital [2] 0 0
Novartis Investigative Site - Westmead
Recruitment hospital [3] 0 0
Novartis Investigative Site - Wentworthville
Recruitment postcode(s) [1] 0 0
- Clayton
Recruitment postcode(s) [2] 0 0
- Westmead
Recruitment postcode(s) [3] 0 0
- Wentworthville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
Belgium
State/province [4] 0 0
Brussels
Country [5] 0 0
Belgium
State/province [5] 0 0
Leuven
Country [6] 0 0
Germany
State/province [6] 0 0
Frankfurt
Country [7] 0 0
Puerto Rico
State/province [7] 0 0
San Juan
Country [8] 0 0
Spain
State/province [8] 0 0
Barcelona
Country [9] 0 0
Spain
State/province [9] 0 0
Sevilla
Country [10] 0 0
Taiwan
State/province [10] 0 0
ROC
Country [11] 0 0
Taiwan
State/province [11] 0 0
Kaohsiung

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a study designed to identify a dose of NIM811 that has a good safety profile, is well
tolerated when co-administered with SOC, and provides a clinically meaningful effect in viral
load reduction compared to SOC alone. This information will be used to support doses selected
for future studies.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00983060
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00983060