Study of PPI-668, BI 207127 and Faldaprevir, With and Without Ribavirin, in the Treatment of Chronic Hepatitis C
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)
1 other identifier
interventional
38
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 17, 2013
CompletedFirst Posted
Study publicly available on registry
May 22, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedNovember 25, 2015
November 1, 2015
1 year
May 17, 2013
November 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the proportion of patients achieving sustained viral response (SVR)
12 weeks after the end of treatment
Secondary Outcomes (4)
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
up to 24 weeks post-treatment
Proportion of patients with confirmed viral breakthrough during study treatment
up to 12 weeks of study treatment
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
up to 12 weeks of study treatment
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
up to 12 weeks of study treatment
Study Arms (3)
PPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin
ACTIVE COMPARATORPPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin dosed in combination
PPI-668, BI 207127 Dose 2, Faldaprevir, and Ribavirin
ACTIVE COMPARATORPPI-668, BI 207127 Dose 2, BI 207127 Placebo, Faldaprevir, and Ribavirin dosed in combination
PPI-668, BI 207127 Dose 1, and Faldaprevir
ACTIVE COMPARATORPPI-668, BI 207127 Dose 1, and Faldaprevir dosed in combination
Interventions
Eligibility Criteria
You may qualify if:
- 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
- Body weight greater than 40 kg and less than 125 kg
- Clinical diagnosis of chronic hepatitis C
- Treatment-naïve for hepatitis C: no previous treatment with interferon, pegylated interferon, ribavirin, telaprevir, boceprevir, or any investigational therapies for hepatitis C
- No symptoms or signs of intercurrent illness at Screen (other than those attributable to hepatitis C)
- No clinically significant abnormalities in the 12-lead electrocardiogram at Screen
- Signed informed consent prior to trial participation.
You may not qualify if:
- Seropositive for HIV antibody or Hepatitis B Surface Antigen at Screen
- Liver disease due to causes other than chronic HCV infection
- Symptoms or signs of decompensated liver disease, or evidence of cirrhosis
- Any medical condition that may interfere with the absorption, distribution or elimination of study drugs
- Poorly controlled or unstable hypertension at Screen.
- 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).
- Red blood cell disorder, including (but not limited to): thalassemia major or minor, sickle cell anemia.
- Diabetes Mellitus treated with insulin or hypoglycemic agents
- History of asthma requiring hospital admission within the preceding 12 months
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Presidio Pharmaceuticals, Inc.lead
- Boehringer Ingelheimcollaborator
Study Sites (1)
Quest Clinical Research
San Francisco, California, 94115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nathaniel Brown, MD
Presidio Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2013
First Posted
May 22, 2013
Study Start
May 1, 2013
Primary Completion
May 1, 2014
Study Completion
December 1, 2014
Last Updated
November 25, 2015
Record last verified: 2015-11