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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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16 December 2017 |
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Main ID: |
NCT02517515 |
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Date of registration:
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05/08/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection
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Scientific title:
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A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection |
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Date of first enrolment:
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July 2015 |
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Target sample size:
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650 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02517515 |
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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: Double (Participant, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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China
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Korea, Republic of
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Taiwan
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Contacts
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Name:
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AbbVie Inc. |
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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:
- Chinese, South Korean, and Taiwanese descent with full Chinese, South Korean, and
Taiwanese parentage
- Chronic hepatitis C virus (HCV) infection prior to study enrollment.
- Screening laboratory result indicating HCV subtype 1b (GT1b) infection.
- Per local standard practice, documented absence of cirrhosis.
- Participant has never received antiviral treatment (including interferon [IFN]-based
therapy [alpha, beta or pegylated (peg)IFN] with or without RBV) for HCV infection
(treatment-naïve participant) or participant must have documentation that they met the
definition of one of the following categories (treatment experienced participant):
Non-responder or Relapser
- Participant has plasma HCV RNA level > 10,000 IU/mL at Screening.
Exclusion Criteria:
- HCV genotype performed during screening indicating unable to genotype or infection
with any HCV genotype other than GT1b.
- Positive test result at Screening for hepatitis B surface antigen (HBsAg), or
hepatitis B virus DNA (HBV-DNA) > Lower Limit of Quantification (LLOQ) if HBsAg
negative, or anti-human immunodeficiency virus antibody (HIV Ab) positive.
- Any current or past clinical evidence of cirrhosis.
- Any primary cause of liver disease other than chronic HCV infection.
- Screening laboratory analyses showing abnormal kidney, hepatic, or hematologic
function.
- Use of known strong inducers of cytochrome P450 3A (CYP3A) or strong inhibitors of
cytochrome P450 3A (CYP2C8) within 2 weeks or within 10 half-lives, whichever is
longer, of the respective medication/supplement prior to study drug administration.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hepatitis C Virus (HCV)
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Intervention(s)
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Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir
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Drug: Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir
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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 active study drug]
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Percentage of Participants With Sustained Virologic Response 24 Weeks Post-treatment (SVR24)
[Time Frame: 24 weeks after the last actual dose of active study drug]
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Secondary Outcome(s)
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Percentage of Participants With Post-treatment Relapse by Post-treatment Week 12
[Time Frame: From the end of treatment through 12 weeks after the last dose of active study drug]
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Percentage of Participants With Post-treatment Relapse by Post-treatment Week 24
[Time Frame: From the end of treatment through 24 weeks after the last dose of active study drug]
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Percentage of Participants With On-treatment Virologic Failure
[Time Frame: up to 12 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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