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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 July 2021 |
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Main ID: |
NCT02292719 |
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Date of registration:
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13/11/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir With Sofosbuvir With or Without Ribavirin in Adults With Chronic Hepatitis C Virus Infection
Quartz II/III |
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Scientific title:
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A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of the Co-Administration of Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) With Sofosbuvir (SOF) With or Without Ribavirin (RBV) in Subjects With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection or Genotype 3 HCV Infection With or Without Cirrhosis |
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Date of first enrolment:
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December 19, 2014 |
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Target sample size:
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70 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02292719 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Australia
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Canada
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New Zealand
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United Kingdom
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United States
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Contacts
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Name:
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Mariem Charafeddine, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AbbVie |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Chronic HCV infection prior to study enrollment.
2. Screening laboratory results from the central clinical laboratory indicating HCV
genotype 2 or 3 infection only (no mixed genotype).
3. Absence OR presence of cirrhosis.
4. If cirrhotic, need to have compensated cirrhosis and absence of hepatocellular
carcinoma (HCC)
Exclusion Criteria:
1. Positive screen for hepatitis B surface antigen or anti-human immunodeficiency virus
antibody
2. Recent (within 6 months prior to study drug administration) history of drug or alcohol
abuse.
3. Current enrollment in another clinical study, previous enrolment in this study, or
previous use of any investigational or commercially available anti-HCV therapy (other
than interferon, pegIFN, RBV, and or SOF) including previous exposure to telaprevir,
boceprevir, ABT-450, or ombitasvir (ABT-267).
4. Subjects without cirrhosis: Any current or past clinical evidence of cirrhosis.
5. Abnormal lab tests.
6. Females who are pregnant or plan to become pregnant or breastfeeding, or males whose
partners are pregnant or planning to become pregnant
Age minimum:
18 Years
Age maximum:
99 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Hepatitis C Virus Infection
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Intervention(s)
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Drug: Ribavirin (RBV)
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Drug: OBV/PTV/r
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Drug: Sofosbuvir
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Primary Outcome(s)
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Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
[Time Frame: 12 weeks after the last actual dose of study drug]
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Secondary Outcome(s)
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Percentage of Participants With Post-treatment Relapse
[Time Frame: Up to 12 weeks after the last actual dose of active study drug]
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Percentage of Participants With On-treatment Virologic Failure
[Time Frame: Up to Week 12]
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Secondary ID(s)
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2014-003147-35
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M14-567
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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