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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
Sponsor:
Collaborator:
Vertex Pharmaceuticals Incorporated
Information provided by (Responsible Party):
Alios Biopharma Inc.

Study Description
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Brief Summary:
The purpose of the study is to determine the safety, pharmacokinetics and efficacy of orally administered VX-135 with ribavirin in treatment naive subjects with chronic hepatitis C infection.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: VX-135 Drug: Ribavirin Phase 2

Detailed Description:

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 Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin

Arms and Interventions
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Arm Intervention/treatment
Experimental: VX-135 low dose in combination with ribavirin
12 weeks of VX-135 in combination with ribavirin
 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


Outcome Measures
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Primary Outcome Measures :
  1. Safety [ Time Frame: Week 12 ]
    The safety and tolerability as assessed by evaluating adverse events and laboratory testing.


Secondary Outcome Measures :
  1. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
Moldova, Republic of
Arensia, Republican Clinical Hospital
Chisinau, Moldova, Republic of
Sponsors and Collaborators
Alios Biopharma Inc.
Vertex Pharmaceuticals Incorporated
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Alios Biopharma Inc.
ClinicalTrials.gov Identifier: NCT01790100     History of Changes
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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents