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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Achillion Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01700179

First received: October 2, 2012

Last updated: April 3, 2013

Last verified: April 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	October 2, 2012
Last Updated Date	April 3, 2013
Start Date ^ICMJE	September 2012
Estimated Primary Completion Date	August 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 2, 2012)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01700179 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 2, 2012)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluation of Safety Tolerability and Antiviral Activity of ACH-0143102 Plus RBV Treatment Naive HCV GT1b Subjects
Official Title ^ICMJE	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.
Brief Summary	ACH-0143102 plus ribavirin will lower viral load in hepatitis C genotype 1b treatment naive subjects.
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Chronic Hepatitis C Infection
Intervention ^ICMJE	Drug: ACH-0143102 Drug: Ribavirin
Study Arm (s)	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. Interventions: Drug: ACH-0143102 Drug: Ribavirin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	16
Estimated Completion Date	November 2013
Estimated Primary Completion Date	August 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 85 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01700179
Other Study ID Numbers ^ICMJE	ACH102-005
Has Data Monitoring Committee	No
Responsible Party	Achillion Pharmaceuticals
Study Sponsor ^ICMJE	Achillion Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Achillion Pharmaceuticals
Verification Date	April 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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