Clinical trial NCT01970904: Pharmacokinetics, Pharmacodynamics and Safety of DEB025 Plus Ribavirin in Chronic Hepatitis C Genotype 2 and 3 Treatment naïve Patients
Official title: A Multicenter, Open-label, Randomized, 3-arm, Phase II Profiling Trial of Pharmacokinetics, Pharmacodynamics and Safety of DEB025/Alisporivir in Combination With Ribavirin Therapy in Chronic Hepatitis C Genotype 2 and 3 Treatment naïve Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Liver Disease
Keywords: Chronic hepatitis C
DEB025
Alisporivir
ribavirin therapy
genotype 2/3 treatment naive patients
Lead sponsor: Debiopharm International SA
Sponsor class: INDUSTRY
First posted: 2013-10-28
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will explore the relationship of different DEB025 doses in combination with RBV to pharmacokinetic, pharmacodynamic (i.e. viral load reduction) and safety profiles in chronic hepatitis C GT 2 and 3 treatment naïve patients.


Eligibility criteria: Inclusion Criteria:

1. Written informed consent must be obtained before any assessment is performed.
2. No previous treatment for Hepatitis C (HCV) infection (i.e. HCV treatment-naïve)
3. Chronic hepatitis C (G2 or G3) virus infection diagnosed

Exclusion criteria:

1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of that medication before enrollment.
2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
3. Hepatitis B Surface Antigen (HBsAg) positive
4. Human immunodeficiency virus (HIV) positive.

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Primary outcomes:
measure: Viral load drop from baseline through Week 12
timeFrame: Baseline through Week 12
measure: Percentage of participants who developed confirmed Stage II or greater hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg
timeFrame: within 12 weeks
measure: Change in platelet count from baseline through Week 12.
timeFrame: Baseline through Week 12
Secondary outcomes:
measure: Number of participants with Sustained Virologic Response at Week 12 follow-up (SVR12)
timeFrame: 12 weeks after the end of treatment
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Duesseldorf
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Freiburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Kiel
country: Germany
facility: Novartis Investigative Site
city: Köln
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Würzburg
country: Germany
facility: Novartis Investigative Site
city: Bialystok
country: Poland
facility: Novartis Investigative Site
city: Lublin
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Göteborg
country: Sweden
facility: Novartis Investigative Site
city: Luleå
country: Sweden
facility: Novartis Investigative Site
city: Lund
country: Sweden
facility: Novartis Investigative Site
city: Malmo
country: Sweden
facility: Novartis Investigative Site
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
city: Umea
country: Sweden
facility: Novartis Investigative Site
city: Frimley
country: United Kingdom
facility: Novartis Investigative Site
state: Surrey
city: Birmingham
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: