Who is sponsoring PEARL-I?

PEARL-I is sponsored by AbbVie (prior sponsor, Abbott).

What condition does PEARL-I study?

PEARL-I studies Hepatitis C, Chronic.

What drugs are being tested in PEARL-I?

Interventions: ABT-450/r, ABT-267, Ribavirin (RBV).

What is the status of PEARL-I?

PEARL-I is currently COMPLETED.

Last reviewed 2021-07-28 · How we verify

A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Coadministration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection (PEARL-I)

NCT01685203 Phase 2 COMPLETED Results posted

The purpose of this study is to evaluate the safety and efficacy of co-administration of ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as ombitasvir) in adults with chronic hepatitis C virus infection.

Details

Lead sponsor	AbbVie (prior sponsor, Abbott)
Phase	Phase 2
Status	COMPLETED
Enrolment	316
Start date	2012-08
Completion	2015-02

Conditions

Hepatitis C, Chronic

Interventions

ABT-450/r
ABT-267
Ribavirin (RBV)

Primary outcomes

Percentage of Participants in Each Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment — 12 weeks after the last actual dose of study drug
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\<LLOQ\]) 12 weeks after the last dose of study drug.