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: August 26, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to evaluate the safety, tolerability and efficacy of 12 weeks of treatment with sovaprevir, ACH-0143102 and ribavirin in GT1, treatment-naive, HCV subjects.


Condition Intervention Phase
Hepatitis C, Chronic
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)
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:
  • To 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 ]
    To determine the incidence of SVR4 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) as compared to those who received placebo.

  • To determine the safety and tolerability of 12 weeks of sovaprevir and 3102 in combination with ribavirin in subjects with chronic hepatitis C genotype 1 viral infection. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    To determine safety and tolerability of 12 weeks of sovaprevir/ACH-0143102/RBV in subjects with chronic hepatitis C genotype 1. The following criteria will be used for safety determination: discontinuations due to AEs, AEs in> 10% of subjects, treatment emergent G3/G4 laboratory abnormalities, clinically significant ECGs.


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
Active Comparator: Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg
Sovaprevir 200 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks
Drug: Sovaprevir
NS3/4A protease inhibitor
Other Name: ACH-0141625
Drug: ACH-3102
NS5A inhibitor
Drug: Ribavirin
Other Name: Ribasphere
Active Comparator: Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-2000mg
Sovaprevir 400 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks
Drug: Sovaprevir
NS3/4A protease inhibitor
Other Name: ACH-0141625
Drug: ACH-3102
NS5A inhibitor
Drug: Ribavirin
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 RBV QD for 12 weeks
Drug: Placebo

  Eligibility

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

Inclusion Criteria:

  • Males and Females between ages 18 and 65
  • Chronic HCV infection
  • HCV genotype 1
  • HCV RNA > 10,000 IU/mL at screening.
  • Female patients must be willing to use two effective methods of contraception, one of which must be barrier method, during dosing period and six months after last dose of ribavirin. Females of childbearing potential must have a negative pregnancy test at screening and baseline.
  • Male patients must be willing to use an effective barrier method of contraception throughout the dosing period and for six months.
  • 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)
  • Use of dietary supplements, grapefruit juice, herbal supplements, CYP2C8 substrates, CYP3A4 inducers and inhibitors, PGP inducers and substrates, OATP inhibitors and substrates, and potent inducers of other CYP enzymes within 14 days prior to dosing through 7 days following completion of study meds.
  • Clinically significant laboratory abnormality at screening (specified in protocol)
  • Other forms of liver disease
  • History of severe or uncontrolled psychiatric disease
  • History of malignancy of any organ system, treated or untreated within the past 5 years
  • History of major organ transplantation
  • Use of bone marrow colony stimulating factor agents within 3 months prior to baseline.
  • History of seizure disorder requiring ongoing medical therapy
  • History of known coagulopathy including hemophilia
  • History of hemoglobinopathy, including sickle cell anemia and thalassemia.
  • History of immunologically mediated disease (specified in protocol)
  • History of clinical evidence of significant chronic cardiac disease ( specified in protocol)
  • ECG with any clinically significant abnormality.
  • Structural or functional cardiac abnormalities (specified in protocol)
  • History of COPD, emphysema, or other chronic lung disease.
  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
Franco Felizarta
Bakersfield, California, United States, 93301
eStudy Site
La Mesa, California, United States, 91942
United States, Georgia
Gastrointestinal Specialists of Georgia
Marietta, Georgia, United States, 30060
United States, Tennessee
Nashville Gastrointestinal Specialists
Nashville, Tennessee, United States, 78215
United States, Texas
Liver Associates of Texas PA
Houston, Texas, United States, 77030
American Research Corporation
San Antonio, Texas, United States, 78215
United States, Virginia
Medical Associates of Central Virginia
Lynchburg, Virginia, United States, 24501
Canada, Ontario
Toronto Liver Centre
Toronto, Ontario, Canada, M6H3M1
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: August 26, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

ClinicalTrials.gov processed this record on October 21, 2014