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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02207088
Other study ID # M14-226
Secondary ID 2014-001527-77
Status Completed
Phase Phase 3
First received July 31, 2014
Last updated October 13, 2017
Start date September 23, 2014
Est. completion date December 6, 2016

Study information

Verified date October 2017
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This open-label study will evaluate safety, pharmacokinetics and efficacy of a 12 or 24-week regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in HCV-genotype 1-infected subjects with an Estimated Glomerular Filtration Rate (eGFR) <30, including those on hemodialysis or peritoneal dialysis.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date December 6, 2016
Est. primary completion date December 6, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

1. Positive for anti-HCV Ab (Antibody) and HCV RNA >1,000 IU/mL at Screening.

2. Screening laboratory result indicating HCV genotype 1 infection.

3. Subject has never received antiviral treatment for hepatitis C infection (treatment-naive subject) or subject has received previous treatment with peginterferon with or without RBV with non-response (HCV RNA quantifiable at end of treatment or relapsed after end of treatment).

4. Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m^2 as estimated by the Modification of Diet in Renal Disease (MDRD) method.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding.

2. Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency Virus (HIV Ab).

3. Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation such as ascites (noted on physical exam), variceal bleeding, or hepatic encephalopathy.

Study Design


Intervention

Drug:
ombitasvir/paritaprevir/ritonavir
tablet
dasabuvir
tablet
Ribavirin
tablet

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification ( 12 weeks after the last actual dose of study drug
Secondary Percentage of Participants With On-treatment Virologic Failure On-treatment virologic failure was defined as confirmed HCV RNA = LLOQ after < LLOQ during treatment, confirmed increase of > 1 log (subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment, or HCV RNA = LLOQ persistently during treatment with at least 6 weeks of treatment. Up to 24 weeks
Secondary Percentage of Participants With Post-Treatment Relapse Post-treatment relapse was defined as confirmed HCV RNA = LLOQ between end of treatment and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA < LLOQ at the end of treatment. Within 12 weeks after the last dose of study drug
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