Clinical trial NCT01849562: Safety, Tolerability, and Efficacy of 12-weeks of Sovaprevir, ACH-3102, and Ribavirin in Treatment-naive GT-1 HCV Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C, Chronic
Keywords: Chronic Hepatitis C
Genotype 1
Hepatitis C
Liver Diseases
Hepatitis
Ribavirin
Antiviral Agents
Anti-infective Agents
Protease Inhibitors
NS5a Inhibitors
Viral
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Achillion, a wholly owned subsidiary of Alexion
First posted: 2013-05-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence Of Sustained Virologic Response 4 Weeks (SVR4) After The Completion Of Treatment
timeFrame: Four weeks after the completion of treatment
measure: Safety And Tolerability Of 12 Weeks Of Sovaprevir And ACH-3102 In Combination With RBV In GT-1 HCV Participants
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: