Evaluation of Safety Tolerability and Antiviral Activity of ACH-0143102 Plus RBV Treatment Naive HCV GT1b Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Achillion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01700179
First received: October 2, 2012
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

ACH-0143102 plus ribavirin will lower viral load in hepatitis C genotype 1b treatment naive subjects.


Condition Intervention Phase
Chronic Hepatitis C Infection
Drug: ACH-0143102
Drug: Ribavirin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1b, Open-label, Pilot Study to Evaluate the Safety, Tolerability and Antiviral Activity of Oral ACH-0143102 Administered in Combination With Ribavirin for 12 Weeks in Treatment Naive Subjects With Chronic Hepatitis C Virus Infection Genotype 1b.

Resource links provided by NLM:


Further study details as provided by Achillion Pharmaceuticals:

Primary Outcome Measures:
  • SVR12 [ Time Frame: 12 weeks following last dose ] [ Designated as safety issue: No ]
    To determine the incidence of a sustained virologic response at 12 weeks after the completion of dosing (SVR12) with ACH-0143102 plus ribavirin, reported as HCV RNA less than the limit of quantification (<LOQ) at that time point


Secondary Outcome Measures:
  • Safety and tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Adverse events, ECG, Vital Signs, Physical Exams and clinical laboratory evaluations.

  • To determine complete early virologic response(cEVR) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    To determine the incidence of a complete early virologic response (cEVR), defined as HCV RNA reported as undetectable at Week 12, for combination therapy of ACH-0143102 plus RBV for 12 weeks in subjects with HVC infection genotype 1b.

  • To determine the incidence of a rapid virologic response(RVR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To determine the incidence of a rapid virologic response (RVR), defined as HCV RNA<limit of quantification(LOQ) at Week 4, for combination therapy of ACH-0143102 plus RBV in subjects with HCV infection genotype 1b.

  • To determine the incidence of an extended rapid virologic response(eRVR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To determine the incidence of an extended rapid virologic response(eRVR), defined as HCV RNA reported as undetectable at Weeks 4 and 12, for subjects treated with combination therapy of ACH-0143102 plus RBV in subjects infected with hepatitis C virus genotype 1b.

  • To determine the incidence of a sustained virologic response [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    To determine the incidence of a sustained virologic response at 4,8, and 24 weeks after the completion of dosing(SVR4,SVR12,and SVR24) with ACH-0143102 plus ribavirin, reported as HCV RNA less than the limit of quantification(<LOQ) at those time points.

  • To determine the pharmacokinetic and pharmacodynamic relationship of ACH-0143102 and RBV treatment and virologic response [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    AUC,Cmax,Tmax,virologic response.


Enrollment: 8
Study Start Date: September 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACH-0143102 plus ribavirin
ACH-0143102 225 mg loading dose on Day 1 followed by 75 mg maintenance dose for 12 weeks plus RBV either 1000mg if weight <75 kg or 1200 mg if weight > 75 kg.
Drug: ACH-0143102 Drug: Ribavirin

Detailed Description:

A phase 1b, pilot study to evaluate the safety, tolerability and antiviral activity of oral ACH-0143102 administered in combination with ribavirin for 12 weeks in treatment naive subjects with chronic hepatitis C virus infection genotype 1b.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Hepatitis C with genotype 1b
  • Chronic hepatitis C treatment naive subjects

Exclusion Criteria:

  • BMI>36
  • pregnant or nursing females
  • clinically significant laboratory abnormalities at screening
  • previous participation in a clinical trial with protease inhibitor and/or NS5A inhibitor
  • HIV infection or other liver diseases
  • Positive Hepatitis B Surface Antigen
  • Liver cirrhosis
  • uncontrolled psychiatric disease
  • clinical evidence of chronic cardiac disease
  • history of malignancy of any organ system within 5 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01700179

Locations
United States, California
Dr. Franco Felizarta
Bakersfield, California, United States, 93301
United States, Georgia
Dr. Aasim Sheikh
Marietta, Georgia, United States, 30060
United States, Tennessee
Dr. Robert Herring Jr
Nashville, Tennessee, United States, 37211
United States, Texas
Victor Ankoma-Sey
Houston, Texas, United States, 77030
Dr. Eric Lawitz
San Antonio, Texas, United States, 78215
United States, Virginia
Vinod Rustgi, MD
Fairfax, Virginia, United States, 22031
Robert Brennan
Lynchburg, Virginia, United States, 24501
Michael Ryan, MD
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Achillion Pharmaceuticals
  More Information

No publications provided

Responsible Party: Achillion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01700179     History of Changes
Other Study ID Numbers: ACH102-005
Study First Received: October 2, 2012
Last Updated: July 10, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 18, 2014