Clinical trial NCT01859962: Study of PPI-668, BI 207127 and Faldaprevir, With and Without Ribavirin, in the Treatment of Chronic Hepatitis C
Official title: A Phase 2a Study of PPI-668 in Combination With BI 207127 and Faldaprevir, With and Without Ribavirin, in Treatment-Naive Patients With Chronic Hepatitis C (HCV Genotype 1a)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C
Keywords: Liver diseases
Virus diseases
Ribavirin
protease inhibitor
NS5B polymerase inhibitor
NS5A inhibitor
Lead sponsor: Presidio Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Boehringer Ingelheim
First posted: 2013-05-22
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: the proportion of patients achieving sustained viral response (SVR)
timeFrame: 12 weeks after the end of treatment
Secondary outcomes:
measure: Proportion of patients with "virologic relapse" post-treatment, defined as confirmed and quantifiable (>LLOQ) serum HCV RNA in a patient who achieved non-detectable serum HCV RNA by the end of treatment
timeFrame: up to 24 weeks post-treatment
measure: Proportion of patients with confirmed viral breakthrough during study treatment
timeFrame: up to 12 weeks of study treatment
measure: Proportions of study participants who receive at least one dose of study drug and who prematurely discontinue study treatment, and proportions prematurely discontinuing treatment for clinical adverse events or laboratory abnormalities
timeFrame: up to 12 weeks of study treatment
measure: Proportions of study participants experiencing treatment-emergent adverse events (serious and non-serious) considered to be possibly or probably attributable to study treatment, overall and by body system
timeFrame: up to 12 weeks of study treatment
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Quest Clinical Research
state: California
Study officials:
affiliation: Presidio Pharmaceuticals, Inc.
name: Nathaniel Brown, MD
role: STUDY_DIRECTOR
References: