Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: October 2, 2014
Last verified: October 2014

October 2, 2012
October 2, 2014
September 2012
September 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01700179 on ClinicalTrials.gov Archive Site
Not Provided
  • 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.
Not Provided
Not Provided
 
Evaluation of Safety Tolerability and Antiviral Activity of ACH-0143102 Plus RBV Treatment Naive HCV GT1b Subjects
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.

The purpose of this study is to evaluate the safety, tolerability and efficacy of 12 weeks of treatment with ACH-0143102 and ribavirin in GT1b, treatment-naive, HCV subjects.

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis C Infection
  • Drug: ACH-0143102
  • Drug: Ribavirin
Experimental: ACH-0143102 plus ribavirin daily
ACH-0143102 225 mg loading dose on Day 1 followed by 75 mg maintenance dose on Days 2-84. Weight-based RBV(as per label) for Days 1-84.
Interventions:
  • Drug: ACH-0143102
  • Drug: Ribavirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females 18 years and older
  • Clinical diagnosis of hepatitis C with genotype 1b
  • Chronic hepatitis C treatment naive subjects
  • IL28B genotype CC
  • HCV RNA > 10000 IU/mL at screening
  • Females must be willing to use two effective methods of contraception during dosing period and for six months after the last dose of ribavirin.
  • Male patients must be willing to use an effective barrier method of contraception throughout the dosing period and for six months after the last dose of ribavirin. Males must agree to not donate sperm while enrolled in the study and for six months after the last dose of ribavirin.
  • Willing to participate in all study activities and all study requirements.

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01700179
ACH102-005
No
Achillion Pharmaceuticals
Achillion Pharmaceuticals
Not Provided
Not Provided
Achillion Pharmaceuticals
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP