Study of PPI-668, BI 207127 and Faldaprevir, With and Without Ribavirin, in the Treatment of Chronic Hepatitis C
NCT ID: NCT01859962
Last Updated: 2015-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
38 participants
INTERVENTIONAL
2013-05-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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PPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin
PPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin dosed in combination
PPI-668
BI 207127 Dose 1
Faldaprevir
Ribavirin
PPI-668, BI 207127 Dose 2, Faldaprevir, and Ribavirin
PPI-668, BI 207127 Dose 2, BI 207127 Placebo, Faldaprevir, and Ribavirin dosed in combination
PPI-668
BI 207127 Dose 2
Faldaprevir
Ribavirin
BI 207127 Placebo
PPI-668, BI 207127 Dose 1, and Faldaprevir
PPI-668, BI 207127 Dose 1, and Faldaprevir dosed in combination
PPI-668
BI 207127 Dose 1
Faldaprevir
Interventions
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PPI-668
BI 207127 Dose 1
BI 207127 Dose 2
Faldaprevir
Ribavirin
BI 207127 Placebo
Eligibility Criteria
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Inclusion Criteria
2. Body weight greater than 40 kg and less than 125 kg
3. Clinical diagnosis of chronic hepatitis C
4. Treatment-naïve for hepatitis C: no previous treatment with interferon, pegylated interferon, ribavirin, telaprevir, boceprevir, or any investigational therapies for hepatitis C
5. No symptoms or signs of intercurrent illness at Screen (other than those attributable to hepatitis C)
6. No clinically significant abnormalities in the 12-lead electrocardiogram at Screen
7. Signed informed consent prior to trial participation.
Exclusion Criteria
2. Liver disease due to causes other than chronic HCV infection
3. Symptoms or signs of decompensated liver disease, or evidence of cirrhosis
4. Any medical condition that may interfere with the absorption, distribution or elimination of study drugs
5. Poorly controlled or unstable hypertension at Screen.
6. Clinically significant, unstable cardiovascular or pulmonary disease, including cardiovascular or pulmonary disease requiring pharmacologic intervention other than anti-hypertensive medications, statins, and/or prophylactic aspirin (or similar anticoagulant).
7. Red blood cell disorder, including (but not limited to): thalassemia major or minor, sickle cell anemia.
8. Diabetes Mellitus treated with insulin or hypoglycemic agents
9. History of asthma requiring hospital admission within the preceding 12 months
10. History of alcohol abuse or illicit drug use which could interfere with a patient's compliance with the protocol requirements, or with the safety or efficacy assessments in this study
11. Patients requiring treatment, during this study, with any of the medications on the restricted medications list (provided in the investigator site file), are not eligible for this study due to considerations of possible drug interactions with the study drug regimen.
18 Years
65 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Presidio Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Nathaniel Brown, MD
Role: STUDY_DIRECTOR
Presidio Pharmaceuticals, Inc.
Locations
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Quest Clinical Research
San Francisco, California, United States
Countries
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Other Identifiers
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PPI-668-201
Identifier Type: -
Identifier Source: org_study_id