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Completed

NCT Number: NCT01859962

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

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.

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Quest Clinical Research

San Francisco, California, 94115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PPI-668

Drug

BI 207127 Dose 1

Drug

BI 207127 Dose 2

Drug

Faldaprevir

Drug

Ribavirin

Drug

BI 207127 placebo

Drug

Primary outcomes

  1. the proportion of patients achieving sustained viral response (SVR)

    Time frame: 12 weeks after the end of treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Presidio Pharmaceuticals, Inc.

Industry

Collaborators

  • Boehringer Ingelheim

Registry information

Official study 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)

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 22, 2013
Registry last updated
Nov 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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