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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
147
Alisporivir 100 mg or 200 mg soft gel capsules (SGC) in blister packs for oral administration
Ribavirin tablets of various strengths for oral administration
Peg-IFNα2a solution for subcutaneous injection
Novartis Investigative Site
Berlin, Germany
Viral load drop from baseline through Week 12
Time frame: Baseline through Week 12
Percentage of participants who developed confirmed Stage II or greater hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg
Time frame: within 12 weeks
Change in platelet count from baseline through Week 12.
Time frame: Baseline through Week 12
Number of participants with Sustained Virologic Response at Week 12 follow-up (SVR12)
Time frame: 12 weeks after the end of treatment
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Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Cologne, Germany
Novartis Investigative Site
Düsseldorf, Germany
Novartis Investigative Site
Frankfurt, Germany
Novartis Investigative Site
Freiburg im Breisgau, Germany
Novartis Investigative Site
Hamburg, Germany
Novartis Investigative Site
Hamburg, Germany
Novartis Investigative Site
Hanover, Germany
Novartis Investigative Site
Kiel, Germany
...and 15 more locations