A Study to Evaluate the Safety and Effect of Treatment With Experimental Antiviral Drugs in Combination With Peginterferon Alpha-2a and Ribavirin in People With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie/Abbott Combination Study
|ClinicalTrials.gov Identifier: NCT01609933|
Recruitment Status : Completed
First Posted : June 1, 2012
Results First Posted : June 19, 2018
Last Update Posted : June 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C||Drug: ABT-450/r Drug: ABT-267 Drug: pegylated interferon alpha-2a (pegIFN) Drug: Ribavirin (RBV)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Study to Evaluate the Safety, Antiviral Activity and Pharmacokinetics of Direct-Acting Antiviral Agent (DAA) Treatment in Combination With Peginterferon Alpha-2a and Ribavirin (pegIFN/RBV) in Chronic Hepatitis C Virus (HCV) Infected Subjects Who Have Experienced Virologic Failure in a Previous AbbVie or Abbott DAA Combination Study|
|Actual Study Start Date :||December 18, 2012|
|Actual Primary Completion Date :||May 3, 2017|
|Actual Study Completion Date :||May 3, 2017|
Experimental: 2-DAA + PegIFN/RBV
2-direct-acting antiviral (2-DAA: ABT-450 [paritaprevir] 200 mg once daily [QD], ritonavir 100 mg QD, ABT-267 [ombitasvir] 25 mg QD) plus pegylated interferon alpha-2a (pegIFN) 180 mcg once weekly and Ribavirin (RBV) weight-based dosing, 1000 to 1200 mg divided twice daily (BID) for 24 weeks (Substudy 1) and followed by pegIFN and RBV alone for an additional 24 weeks (Substudy 2).
ABT-450 (tablets) dosed with ritonavir (capsules or tablets)
Other Name: ABT-450 also known as paritaprevir and r is also know as ritonavir
Other Name: ABT-267 also known as ombitasvir
Drug: pegylated interferon alpha-2a (pegIFN)
pegIFN alpha-2a (syringe)
Drug: Ribavirin (RBV)
- Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post Treatment (SVR12) [ Time Frame: 12 weeks after last dose of study drugs (DAAs plus pegIFN alpha-2a and RBV); approximately 36 weeks after subject's initial dose of study drug in Substudy 1 ]SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than lower limit of quantitation [LLOQ] 12 weeks after the last dose of study drugs (DAAs plus pegIFN alpha-2a and RBV).
- Percentage of Participants Achieving Virologic Response 24 Weeks Post Treatment (SVR24) [ Time Frame: 24 weeks after last dose of study drugs (DAAs plus pegIFN alpha-2a and RBV); approximately 48 weeks after subject's initial dose of study drug in Substudy 1 ]SVR24 was defined as HCV RNA level less than the LLOQ 24 weeks after the last dose of study drugs (DAAs plus pegIFN alpha-2a and RBV).
- Percentage of Participants With Extended Rapid Virologic Response (eRVR) [ Time Frame: Treatment weeks 4 through 12 of Substudy 1 (DAAs plus pegIFN alpha-2a and RBV) ]eRVR was defined as HCV RNA level < LLOQ at Substudy 1 treatment weeks 4 through 12 without a confirmed HCV RNA >= LLOQ
- Number of Participants With Adverse Events [ Time Frame: From first dose of study drug through 30 days after last dose of study drug (DAAs plus pegIFN alpha-2a and RBV) (up to 28 weeks). ]An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after initiation of study drug through 30 days post-DAA dosing. For more details on AEs, see the AE section.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609933
|Study Director:||AbbVie Inc.||AbbVie|