Safety, Tolerability and Efficacy of 12-weeks of Sovaprevir, ACH-3102 and Ribavirin in Treatment-naive GT-1 HCV Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Achillion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01849562
First received: April 18, 2013
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

To evaluate the safety, tolerability and efficacy of 12 weeks of treatment with sovaprevir, ACH-3102 and ribavirin in GT1, treatment-naive, HCV subjects.


Condition Intervention Phase
Hepatitis C Virus
Drug: sovaprevir
Drug: ACH-3102
Drug: Ribavirin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2a Trial to Evaluate the Safety, Tolerability and Efficacy of 12 Weeks of Sovaprevir, ACH-0143102 and Ribavirin in Treatment-Naive Subjects With Chronic Hepatitis C Genotype-1 Viral Infection

Resource links provided by NLM:


Further study details as provided by Achillion Pharmaceuticals:

Primary Outcome Measures:
  • Determine the Incidence of Sustained Virologic Response 4 weeks (SVR4) after the completion of treatment [ Time Frame: Four weeks after the completion of treatment ] [ Designated as safety issue: No ]
    HCV RNA less than the limit of quantification (<LOQ), in subjects who received active treatment (sovaprevir and ACH-0143102 in combination with ribavirin) as compared to those who received placebo

  • Safety measured via adverse events; laboratory tests, ECGs, vital signs and physical exams. [ Time Frame: Through 12 weeks of treatment ] [ Designated as safety issue: Yes ]
    Adverse events will be assessed for their severity and association with study drug; physical exams, laboratory values, ECGs and vital signs will be assessed and summarized as changes from baseline values.


Secondary Outcome Measures:
  • Determine the incidence of sustained virologic response at 8 weeks (SVR8) following the completion of dosing [ Time Frame: 8 weeks following completion of dosing ] [ Designated as safety issue: No ]
    To determine the incidence of SVR8 weeks after the completion of dosing, reported as HCV RNA less than the limit of quantification (<LOQ) in subjects who received active treatment (sovaprevir and ACH-0143102 in combination with ribavirin)

  • Determine the incidence of sustained virologic response at 12 weeks (SVR12) following the completion of dosing [ Time Frame: 12 weeks following completion of dosing ] [ Designated as safety issue: No ]
    To determine the incidence of SVR12 weeks after the completion of dosing, reported as HCV RNA less than the limit of quantification (<LOQ) in subjects who received active treatment (sovaprevir and ACH-0143102 in combination with ribavirin)

  • Determine the incidence of sustained virologic response at 24 weeks (SVR24) following the completion of dosing [ Time Frame: 24 weeks following completion of dosing ] [ Designated as safety issue: No ]
    To determine the incidence of SVR24 weeks after the completion of dosing, reported as HCV RNA less than the limit of quantification (<LOQ) in subjects who received active treatment (sovaprevir and ACH-0143102 in combination with ribavirin)

  • Determine the incidence of complete early virologic response (cEVR) at the end of the 12-week treatment period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To determine the incidence of complete early virologic response (cEVR) at the end of the 12-week treatment period reported as HCV RNA less than the limit of quantification (<LOQ) target not detected in subjects who received active treatment (sovaprevir and ACH-0143102 in combination with ribavirin) as compared to placebo

  • Determine the incidence of rapid virologic response (RVR) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    To determine the incidence of rapid virologic response (RVR) defined as HCV RNA less than the limit of quantification (<LOQ) target not detected at week 4 in subjects receiving active treatment (sovaprevir and ACH-0143102 in combination with ribavirin) as compared to placebo

  • Determine the incidence of extended rapid virologic response (eRVR) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    To determine the incidence of extended rapid virologic response (eRVR) defined as HCV RNA less than the limit of quantification (<LOQ) target not detected at weeks 4 and 12 in subjects receiving active treatment (sovaprevir and ACH-0143102 in combination with ribavirin) as compared to placebo

  • Pharmacokinetic analysis of trough samples analyzed for concentrations of sovaprevir, ACH-3102 and ribavirin from baseline through week 20. [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
    To determine the PK/PD relationship between the combination treatment regimen (sovaprevir, ACH-0143102 and ribavirin) and virologic response


Enrollment: 30
Study Start Date: April 2013
Study Completion Date: April 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sovaprevir 200 mg/ACH-3102 50 mg
sovaprevir 200 mg capsule QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg capsule QD + weight-based ribavirin BID
Drug: sovaprevir
NS3/4A protease inhibitor
Other Name: ACH-0141625
Drug: ACH-3102
NS5A inhibitor
Other Name: ACH-0143102
Drug: Ribavirin
tablets
Other Name: Ribasphere
Experimental: sovaprevir 400 mg/ACH-3102 50 mg
sovaprevir 400 mg capsule QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg capsule QD + weight-based ribavirin BID
Drug: sovaprevir
NS3/4A protease inhibitor
Other Name: ACH-0141625
Drug: ACH-3102
NS5A inhibitor
Other Name: ACH-0143102
Drug: Ribavirin
tablets
Other Name: Ribasphere
Placebo Comparator: Placebo
Placebo for sovaprevir capsule QD + placebo for ACH-3102 150 mg loading dose on Day 1 followed by 50 mg capsule QD + placebo for weight-based ribavirin BID
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic HCV infection documented by one of the following:
  • HCV genotype 1
  • HCV RNA > 10,000 IU/mL at screening.
  • Signed and dated written informed consent form.
  • Willing to participate in all study activities and all study requirements (including effective contraception) during study period.
  • Treatment naïve subjects defined as subjects who have never received pegylated interferon, RBV, or a direct-acting anti-viral agent for the treatment of chronic HCV infection.
  • A liver biopsy within the last 3 years without evidence of cirrhosis

Exclusion Criteria:

  • Body Mass Index (BMI) > 36.0
  • Pregnant or nursing (lactating) females, confirmed by a positive human chorionic gonadotropin (HCG) laboratory test or females contemplating pregnancy
  • Participation in any interventional clinical trial within 35 days prior to first study medication dose administration on Day 1
  • Known HIV-1 or HIV-2 infection/serology and/or positive Hepatitis B Surface Antigen (HBsAg)
  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: NCT01849562

Locations
United States, California
Bakersfield, California, United States, 93301
Sponsors and Collaborators
Achillion Pharmaceuticals
  More Information

No publications provided

Responsible Party: Achillion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01849562     History of Changes
Other Study ID Numbers: ACH102-007
Study First Received: April 18, 2013
Last Updated: July 10, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
New Zealand: Medsafe
Australia: Therapeutic Goods Administration

Keywords provided by Achillion Pharmaceuticals:
Hepatitis C, Chronic
Genotype 1
Hepatitis C
Liver Diseases
Hepatitis, viral, human
ribavirin
antiviral agents
anti-infective agents
protease inhibitors
NS5a inhibitors

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

ClinicalTrials.gov processed this record on July 26, 2014