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

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Achillion Pharmaceuticals; Alexion Pharmaceuticals
• Treatments: Odalasvir; Protease Inhibitors; Ribavirin

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.

• Subjects currently abusing amphetamines, cocaine or opiates, or with ongoing alcohol abuse in the judgement of the investigator