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

Chronic Hepatitis C Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01859962
• Other study ID #: PPI-668-201
• Status: Completed
• Phase: Phase 2
• First received: May 17, 2013
• Last updated: November 24, 2015
• Start date: May 2013
• Est. completion date: December 2014

Study information

• Verified date: November 2015
• Source: Presidio Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• PPI-668

• BI 207127 Dose 1

• BI 207127 Dose 2

• Faldaprevir

• Ribavirin

• BI 207127 Placebo

Locations

Country	Name	City	State
United States	Quest Clinical Research	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Presidio Pharmaceuticals, Inc.	Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the proportion of patients achieving sustained viral response (SVR)		12 weeks after the end of treatment	No
Secondary	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	No
Secondary	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	up to 12 weeks of study treatment	No
Secondary	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	Yes
Secondary	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	Yes