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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Chronic Hepatitis C	Drug: PPI-668; Drug: BI 207127 Dose 1; Drug: BI 207127 Dose 2; Drug: Faldaprevir; Drug: Ribavirin; Drug: BI 207127 Placebo	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	38 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
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 Start Date :	May 2013
Actual Primary Completion Date :	May 2014
Actual Study Completion Date :	December 2014

Arms and Interventions

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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	Drug: PPI-668 Drug: BI 207127 Dose 1 Drug: Faldaprevir Drug: Ribavirin
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	Drug: PPI-668 Drug: BI 207127 Dose 2 Drug: Faldaprevir Drug: Ribavirin Drug: BI 207127 Placebo
Active Comparator: PPI-668, BI 207127 Dose 1, and Faldaprevir; PPI-668, BI 207127 Dose 1, and Faldaprevir dosed in combination	Drug: PPI-668 Drug: BI 207127 Dose 1 Drug: Faldaprevir

Outcome Measures

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Primary Outcome Measures :

1. the proportion of patients achieving sustained viral response (SVR) [ Time Frame: 12 weeks after the end of treatment ]

Secondary Outcome Measures :

1. 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 ]
2. 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
3. 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 ]
4. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Locations

United States, California
Quest Clinical Research
San Francisco, California, United States, 94115

Sponsors and Collaborators

Presidio Pharmaceuticals, Inc.

Boehringer Ingelheim

Investigators

Study Director:	Nathaniel Brown, MD	Presidio Pharmaceuticals, Inc.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Presidio Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01859962 History of Changes
Other Study ID Numbers:	PPI-668-201
First Posted:	May 22, 2013
Last Update Posted:	November 25, 2015
Last Verified:	November 2015

Keywords provided by Presidio Pharmaceuticals, Inc.:

Liver diseases; Virus diseases; Ribavirin	protease inhibitor; NS5B polymerase inhibitor; NS5A inhibitor

Additional relevant MeSH terms:

Hepatitis; Hepatitis A; Hepatitis C; Hepatitis, Chronic; Hepatitis C, Chronic; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Virus Diseases	Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Flaviviridae Infections; Ribavirin; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antiviral Agents; Anti-Infective Agents