Study of PPI-668, BI 207127 and Faldaprevir, With and Without Ribavirin, in the Treatment of Chronic Hepatitis C

Presidio Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis C

Treatments: Drug: BI 207127 Dose 2; Drug: Faldaprevir; Drug: BI 207127 Dose 1; Drug: Ribavirin; Drug: BI 207127 Placebo; Drug: PPI-668

Study type: Interventional

Funder types: Industry

Identifiers

NCT01859962

PPI-668-201

Details and patient eligibility

About

This study is designed to provide a preliminary assessment of the safety and effectiveness of the combination of PPI-668, BI 207127 and faldaprevir, with or without ribavirin, in the treatment of chronic hepatitis C virus infection.

Enrollment: 38 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female, 18 to 65 years of age; if females are of childbearing potential, then they must be willing to use two non-hormonal methods of birth control
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

1. Seropositive for HIV antibody or Hepatitis B Surface Antigen at Screen
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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38 participants in 3 patient groups

PPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin

Active Comparator group

Description:

PPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin dosed in combination

Treatment:

Drug: Ribavirin

Drug: BI 207127 Dose 1

Drug: Faldaprevir

Drug: PPI-668

PPI-668, BI 207127 Dose 2, Faldaprevir, and Ribavirin

Active Comparator group

Description:

PPI-668, BI 207127 Dose 2, BI 207127 Placebo, Faldaprevir, and Ribavirin dosed in combination

Treatment:

Drug: BI 207127 Dose 2

Drug: Ribavirin

Drug: Faldaprevir

Drug: BI 207127 Placebo

Drug: PPI-668

PPI-668, BI 207127 Dose 1, and Faldaprevir

Active Comparator group

Description:

PPI-668, BI 207127 Dose 1, and Faldaprevir dosed in combination

Treatment:

Drug: BI 207127 Dose 1

Drug: Faldaprevir

Drug: PPI-668