A Phase 2a, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C
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ClinicalTrials.gov Identifier: NCT01790100 |
Recruitment Status :
Completed
First Posted : February 13, 2013
Last Update Posted : December 18, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Hepatitis C | Drug: VX-135 Drug: Ribavirin | Phase 2 |
Up to twenty (20) subjects with CHC GT1 infection will be randomized in a 1:1 ratio (with stratification by IL-28B genotype (CC versus non-CC)) to evaluate VX-135 low dose or high dose both given in combination with RBV for 12 weeks.
Safety and tolerability will be evaluated on an ongoing basis through assessment of adverse events (AEs), lab evaluations and physical examinations. Subjects will be monitored from Day 1 through end of follow-up for virologic breakthrough or relapse.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Phase 2a, Partially-Blind, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C |
Actual Study Start Date : | February 28, 2013 |
Actual Primary Completion Date : | June 30, 2014 |
Actual Study Completion Date : | June 30, 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: VX-135 low dose in combination with ribavirin
12 weeks of VX-135 in combination with ribavirin
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Drug: VX-135
12 weeks of VX-135 Drug: Ribavirin 12 weeks of ribavirin |
Experimental: VX-135 high dose in combination with ribavirin |
Drug: VX-135
12 weeks of VX-135 Drug: Ribavirin 12 weeks of ribavirin |
- Safety [ Time Frame: Week 12 ]The safety and tolerability as assessed by evaluating adverse events and laboratory testing.
- evidence of HCV RNA viral load reduction [ Time Frame: 16 weeks ]The proportion of subjects who have an SVR at 4 weeks after the last planned dose of treatment (SVR4)

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Subjects (male and female) must be between 18-60 years of age
- Subjects must have Chronic Hepatitis C
- Subjects must be treatment naive
- Subjects must have laboratory values at screening within limits as specified by the protocol
Key Exclusion Criteria:
- Evidence of cirrhosis
- Female subjects who are pregnant or nursing or male subjects with a female partner of childbearing potential who is unwilling to adhere to the contraception requirements, is pregnant or nursing, or planning to become pregnant during the study
- any other cause of significant liver disease in addition to hepatitis C
- Diagnosis of or suspected hepatocellular carcinoma

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01790100
Moldova, Republic of | |
Arensia, Republican Clinical Hospital | |
Chisinau, Moldova, Republic of |
Responsible Party: | Alios Biopharma Inc. |
ClinicalTrials.gov Identifier: | NCT01790100 |
Other Study ID Numbers: |
ALS-135-101 2012-005633-37 ( EudraCT Number ) |
First Posted: | February 13, 2013 Key Record Dates |
Last Update Posted: | December 18, 2017 |
Last Verified: | December 2017 |
Studies a U.S. FDA-regulated Device Product: | No |
Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis Hepatitis, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections Enterovirus Infections |
Picornaviridae Infections RNA Virus Infections Blood-Borne Infections Communicable Diseases Flaviviridae Infections Ribavirin Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents |