- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01859962
Study of PPI-668, BI 207127 and Faldaprevir, With and Without Ribavirin, in the Treatment of Chronic Hepatitis C
November 24, 2015 updated by: Presidio Pharmaceuticals, Inc.
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States, 94115
- Quest Clinical Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: PPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin
PPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin dosed in combination
|
|
Active Comparator: PPI-668, BI 207127 Dose 2, Faldaprevir, and Ribavirin
PPI-668, BI 207127 Dose 2, BI 207127 Placebo, Faldaprevir, and Ribavirin dosed in combination
|
|
Active Comparator: PPI-668, BI 207127 Dose 1, and Faldaprevir
PPI-668, BI 207127 Dose 1, and Faldaprevir dosed in combination
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the proportion of patients achieving sustained viral response (SVR)
Time Frame: 12 weeks after the end of treatment
|
12 weeks after the end of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: up to 24 weeks post-treatment
|
up to 24 weeks post-treatment
|
|
Proportion of patients with confirmed viral breakthrough during study treatment
Time Frame: up to 12 weeks of study treatment
|
"Confirmed viral breakthrough" is defined as a > 1 log increase in HCV RNA from post-Baseline nadir value or confirmed increase in HCV RNA ≥LLOQ if HCV RNA previously declined to <LLOQ (detected or not detected), during the 12-week study treatment period
|
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
Time Frame: up to 12 weeks of study treatment
|
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
Time Frame: up to 12 weeks of study treatment
|
up to 12 weeks of study treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Nathaniel Brown, MD, Presidio Pharmaceuticals, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
May 17, 2013
First Submitted That Met QC Criteria
May 20, 2013
First Posted (Estimate)
May 22, 2013
Study Record Updates
Last Update Posted (Estimate)
November 25, 2015
Last Update Submitted That Met QC Criteria
November 24, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis, Chronic
- Hepatitis C, Chronic
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Ribavirin
Other Study ID Numbers
- PPI-668-201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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