Pharmacokinetics, pharmacodynamics and safety DEB025/Alisporivir in combination with ribavirin therapy in chronic hepatitis C genotype 2 and 3 treatment naive patients

• Register: EUCTR
• Last refreshed on: 10 July 2015
• Main ID: EUCTR2012-004185-17-PL
• Date of registration: 07/10/2013
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: Pharmacokinetics, pharmacodynamics and safety DEB025/Alisporivir in combination with ribavirin therapy in chronic hepatitis C genotype 2 and 3 treatment naive patients
• Scientific 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
• Date of first enrolment: 22/11/2013
• Target sample size: 150
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-004185-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 3

Countries of recruitment

Germany, Poland, Sweden, United Kingdom

Contacts

• Affiliation: Novartis Pharma Services AG

• Affiliation: Novartis Pharma Services AG

Key inclusion & exclusion criteria

Inclusion criteria:
1. Written informed consent must be obtained before any assessment is
performed.
2. No previous treatment for Hepatitis C infection (i.e. HCV treatmentnaïve)
3. Chronic hepatitis C virus infection diagnosed
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 33
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

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. History of pancreatitis or history strongly suggestive of previous
pancreatitis
4. HBsAg positive or HIV positive.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Chronic hepatitis C
MedDRA version: 17.0 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations

Intervention(s)

Trade Name: Copegus
Pharmaceutical Form: Tablet
INN or Proposed INN: Ribavirin
CAS Number: 36791-04-5
Other descriptive name: RIBAVIRIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Trade Name: Pegasys
Pharmaceutical Form: Solution for injection
INN or Proposed INN: peginterferon alpha 2a
CAS Number: 198153-51-4
Other descriptive name: PEGINTERFERON ALFA-2A
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 180-

Product Name: alisporivir
Product Code: DEB025
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: alisporivir
CAS Number: 254435-95-5
Current Sponsor code: DEB025
Other descriptive name: ALISPORIVIR
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 100-200

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: treatment week 12

Secondary Objective: Evaluate the SVR12 among 3 treatment groups with different doses of DEB025 in combination with ribavirin in chronic heptatitis C GT2 and 3 treatment naive patients

Primary end point(s): •viral load drop from baseline through week 12
•changes in serum triglycerides from baseline through week 12
•proportion of patients who develop confirmed Stage II or greater hypertension (SBP =160 mm Hg or DBP =100 mm Hg).
•changes in platelet count from baseline through week 12.

Main Objective: Pharmacodynamics, Pharmacokinetic, safety profiles between treatment groups receiving 3 different doses of DEB025 in combination with RBV

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: SVR 12

Secondary end point(s): HCV RNA viral load SVR12

Secondary ID(s)

2012-004185-17-SE

CDEB025A2222

Source(s) of Monetary Support

Novartis Pharma Services AG