Status:
COMPLETED
Safety, Tolerability, and Efficacy of 12-weeks of Sovaprevir, ACH-3102, and Ribavirin in Treatment-naive GT-1 HCV Participants
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Collaborating Sponsors:
Achillion, a wholly owned subsidiary of Alexion
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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, hepat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01849562
Start Date
April 1 2013
End Date
April 1 2014
Last Update
August 29 2023
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