Chronic Hepatitis C Virus (HCV Infection Genotype 1) Clinical Trial
Official title:
An Open-Label, Treatment Duration-Ranging Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/ Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Co-administered With Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Direct-Acting Antiviral Agent (DAA) Treatment-Naive Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
| Verified date | November 2015 |
| Source | AbbVie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Australia: Human Research Ethics Committee |
| Study type | Interventional |
This open-label study will evaluate the safety and efficacy of co-formulated ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with sofosbuvir with or without ribavirin administered for either 4 or 6 weeks in treatment naive adults with chronic HCV-genotype 1 infection without cirrhosis
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | November 2015 |
| Est. primary completion date | November 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 99 Years |
| Eligibility |
Inclusion Criteria: 1. Male or female at least 18 years of age at time of screening 2. Chronic HCV infection prior to study enrollment 3. Screening laboratory results from the central clinical laboratory indicating HCV genotype 1 infection only 4. Absence of cirrhosis and advanced bridging fibrosis Exclusion Criteria: 1. Positive test result for Hepatitis B surface antigen (HbsAg) or HIV positive immunoassay 2. Clinically significant abnormalities or co-morbidities, other than HCV infection, that make the subject an unsuitable candidate for this study or treatment with RBV in the opinion of the investigator 3. Any current or past clinical evidence of cirrhosis such as ascites or esophageal varices, or prior biopsy showing cirrhosis or advanced bridging fibrosis, e.g., a Metavir score > 2 or an Ishak score > 3 4. Use of medications contraindicated for Ombitasvir/Paritaprevir, Dasabuvir, SOF, ritonavir or RBV (for those that receive RBV), within 2 weeks or 10 half-lives whichever is longer, prior to study drug administration 5. Current enrolment in another clinical study, previous enrolment in this study, or previous use of any investigational or commercially available anti-HCV agents |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Site Reference ID/Investigator# 136598 | Adelaide | |
| Canada | Site Reference ID/Investigator# 137903 | Toronto | |
| Canada | Site Reference ID/Investigator# 137904 | Toronto | |
| Canada | Site Reference ID/Investigator# 137906 | Vancouver | |
| Canada | Site Reference ID/Investigator# 137907 | Vancouver | |
| New Zealand | Site Reference ID/Investigator# 136942 | Grafton |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie |
Australia, Canada, New Zealand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of subjects achieving a 12-week sustained virologic response | HCV RNA less than the lower limit of quantification | 12 weeks after the last actual dose of study drug (either 16 or 18 weeks) | No |
| Secondary | Percentage of subjects with on-treatment virologic failure | Percentage of subjects with confirmed HCV RNA >= lower limit of quantification at any time point during treatment, confirmed increase from nadir or failure to suppress during treatment | During 4 or 6 weeks of treatment with study drug (either 4 weeks or 6 weeks) | No |
| Secondary | Percentage of subjects with post-treatment relapse | Percentage of subjects with HCV RNA less than the lower limit of quantification at the end of treatment with confirmed HCV RNA greater than or equal to the lower limit of quantification through 12 weeks post treatment | Up to 12 weeks after last actual dose of active study drug (either 16 or 18 weeks) | No |