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:
Achillion Pharmaceuticals
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
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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.
| Estimated Enrollment: | 16 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | August 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
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: | April 3, 2013 |
| 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 May 22, 2013