Back to results

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

Primary Purpose

Chronic Hepatitis C

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

PPI-668

BI 207127 Dose 1

BI 207127 Dose 2

Faldaprevir

Ribavirin

BI 207127 Placebo

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Liver diseases, Virus diseases, Ribavirin, protease inhibitor, NS5B polymerase inhibitor, NS5A inhibitor

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Quest Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

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

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

PPI-668, BI 207127 Dose 1, and Faldaprevir

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

the proportion of patients achieving sustained viral response (SVR)

Secondary Outcome Measures

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

Proportion of patients with confirmed viral breakthrough during 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

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

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

Full Information

NCT ID

NCT01859962

First Posted

May 17, 2013

Last Updated

November 24, 2015

Sponsor

Presidio Pharmaceuticals, Inc.

Collaborators

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT01859962

Brief Title

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

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

May 2013 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Presidio Pharmaceuticals, Inc.

Collaborators

Boehringer Ingelheim

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis C

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Active Comparator

Arm Description

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

Arm Title

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

Arm Type

Active Comparator

Arm Description

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

Arm Title

PPI-668, BI 207127 Dose 1, and Faldaprevir

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

PPI-668

Intervention Type

Drug

Intervention Name(s)

BI 207127 Dose 1

Intervention Type

Drug

Intervention Name(s)

BI 207127 Dose 2

Intervention Type

Drug

Intervention Name(s)

Faldaprevir

Intervention Type

Drug

Intervention Name(s)

Ribavirin

Intervention Type

Drug

Intervention Name(s)

BI 207127 Placebo

Primary Outcome Measure Information:

Title

the proportion of patients achieving sustained viral response (SVR)

Time Frame

12 weeks after the end of treatment

Secondary Outcome Measure Information:

Title

Time Frame

up to 24 weeks post-treatment

Title

Proportion of patients with confirmed viral breakthrough during study treatment

Description

Time Frame

up to 12 weeks of study treatment

Title

Time Frame

up to 12 weeks of study treatment

Title

Time Frame

up to 12 weeks of study treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nathaniel Brown, MD

Organizational Affiliation

Presidio Pharmaceuticals, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Quest Clinical Research

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs