Ombitasvir/ABT-450/Ritonavir and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naive Genotype 1a Hepatitis C Virus Infected Adults
NCT ID: NCT02493855
Last Updated: 2017-10-31
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
46 participants
INTERVENTIONAL
2015-06-30
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Ribavirin Full Dose for Last 10 Weeks
Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks.
Ombitasvir/ABT-450/Ritonavir
Ombitasvir/ABT-450/ritonavir combination tablets
Dasabuvir
Dasabuvir tablets
Ribavirin (RBV)
Ribavirin tablets
Arm B: Ribavirin Full Dose for 12 Weeks
Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks.
Ombitasvir/ABT-450/Ritonavir
Ombitasvir/ABT-450/ritonavir combination tablets
Dasabuvir
Dasabuvir tablets
Ribavirin (RBV)
Ribavirin tablets
Arm C: Ribavirin Low-dose for 12 Weeks
Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.
Ombitasvir/ABT-450/Ritonavir
Ombitasvir/ABT-450/ritonavir combination tablets
Dasabuvir
Dasabuvir tablets
Ribavirin (RBV)
Ribavirin tablets
Interventions
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Ombitasvir/ABT-450/Ritonavir
Ombitasvir/ABT-450/ritonavir combination tablets
Dasabuvir
Dasabuvir tablets
Ribavirin (RBV)
Ribavirin tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Chronic HCV infection.
3. Subjects must be non-cirrhotic.
4. Subjects must be able to understand and adhere to the study visit schedule and all protocol requirements as well as voluntarily sign and date an institutional review board (IRB) approved informed consent.
Exclusion Criteria
2. Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab) positive immunoassay.
3. Clinically significant abnormalities or co-morbidities, other than HCV infection, that make the subject unsuitable for this study or treatment.
4. Current enrollment in another interventional clinical study. Previous use of any HCV treatments including pegylated interferon (pegIFN), ribavirin, or any direct acting antiviral agent, either investigational or approved, for HCV including protease inhibitors, nucleoside or non-nucleoside polymerase inhibitors, or nonstructural viral protein 5A (NS5A) inhibitors.
5. History or solid organ transplant.
6. Screening laboratory analysis that shows abnormal results.
18 Years
100 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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Emily Dumas, PhD
Role: STUDY_DIRECTOR
AbbVie
Countries
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Other Identifiers
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2014-001478-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M14-242
Identifier Type: -
Identifier Source: org_study_id