Safety, Tolerability, and Efficacy of 12-weeks of Sovaprevir, ACH-3102, and Ribavirin in Treatment-naive GT-1 HCV Participants
Phase 2
Completed
- Conditions
- Hepatitis C, Chronic
- Interventions
- Registration Number
- NCT01849562
- Lead Sponsor
- Alexion Pharmaceuticals, Inc.
- Brief Summary
The purpose of this study was to evaluate the safety, tolerability, and efficacy of 12 weeks of treatment with sovaprevir, ACH-0143102, and ribavirin (RBV) in genotype-1 (GT-1), treatment-naive, hepatitis C virus (HCV) participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Chronic HCV infection.
- HCV GT-1.
- HCV ribonucleic acid > 10,000 international units/milliliter at screening.
- Female participants must be willing to use 2 effective methods of contraception, one of which must be a barrier method, during the dosing period and 6 months after the last dose of RBV. Females of childbearing potential must have a negative pregnancy test at screening and baseline.
- Male participants must be willing to use an effective barrier method of contraception throughout the dosing period and for 6 months.
- Signed and dated written informed consent form.
- Willing to participate in all study activities and all study requirements (including effective contraception) during the study period.
- Treatment-naïve participants were defined as those participants 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 > 36.0 kilograms/meter squared.
- Pregnant or nursing (lactating) female participants confirmed by a positive human chorionic gonadotropin laboratory test or contemplating pregnancy.
- Participation in any interventional clinical trial within 35 days prior to first study medication dose administration on Day 1.
- Known human immunodeficiency virus (HIV)-1 or HIV-2 infection/serology and/or positive hepatitis B surface antigen.
- Use of dietary supplements, grapefruit juice, herbal supplements, cytochrome P450 (CYP) 2C8 substrates, CYP3A4 inducers and inhibitors, P-glycoprotein inducers and substrates, organic-anion-transporting polypeptide inhibitors and substrates, and potent inducers of other CYP enzymes within 14 days prior to dosing through 7 days following completion of study medications.
- 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).
- Electrocardiogram with any clinically significant abnormality.
- Structural or functional cardiac abnormalities (specified in protocol).
- History of chronic obstructive pulmonary disease, emphysema, or other chronic lung disease.
- Participants currently abusing amphetamines, cocaine or opiates, or with ongoing alcohol abuse in the judgement of the investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo for sovaprevir capsule qd + placebo for ACH-3102 150 mg loading dose on Day 1, followed by placebo for 50 mg qd + placebo for weight-based RBV qd for 12 weeks. Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000 -1200 mg Sovaprevir Sovaprevir 400 mg qd + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks. Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000 -1200 mg Ribavirin Sovaprevir 400 mg qd + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks. Sovaprevir 200 milligrams (mg), ACH-3102 150/50 mg, RBV 1000-1200 mg ACH-3102 Sovaprevir 200 mg once daily (qd) + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks. Sovaprevir 200 milligrams (mg), ACH-3102 150/50 mg, RBV 1000-1200 mg Sovaprevir Sovaprevir 200 mg once daily (qd) + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks. Sovaprevir 200 milligrams (mg), ACH-3102 150/50 mg, RBV 1000-1200 mg Ribavirin Sovaprevir 200 mg once daily (qd) + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks. Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000 -1200 mg ACH-3102 Sovaprevir 400 mg qd + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks.
- Primary Outcome Measures
Name Time Method Incidence Of Sustained Virologic Response 4 Weeks (SVR4) After The Completion Of Treatment Four weeks after the completion of treatment Incidence of SVR4 after the completion of dosing, reported as hepatitis C virus (HCV) ribonucleic acid less than the lower limit of quantification, in participants who received active treatment (sovaprevir and ACH-0143102 in combination with RBV) as compared to those who received placebo.
Safety And Tolerability Of 12 Weeks Of Sovaprevir And ACH-3102 In Combination With RBV In GT-1 HCV Participants 12 weeks To determine the safety and tolerability of 12 weeks of sovaprevir/ACH-0143102/RBV treatment in participants with chronic genotype-1 (GT-1) HCV, the following criteria will be used: the number of participants with discontinuations due to adverse events (AEs), treatment-emergent Grade 3/Grade 4 (G3/G4) AEs, treatment-emergent G3/G4 laboratory abnormalities, and clinically significant electrocardiograms (ECGs).
- Secondary Outcome Measures
Name Time Method