Pharmacokinetics, pharmacodynamics and safety of DEB025/alisporivir in combination with ribavirin therapy in chronic hepatitis C genotype 2 and 3 patients who have previously failed interferon therapy or are intolerant or unable to take interferon

• Register: EUCTR
• Last refreshed on: 4 April 2022
• Main ID: EUCTR2013-003751-38-FR
• Date of registration: 17/06/2015
• Prospective Registration: No
• Primary sponsor: Novartis Pharma Services AG
• Public title: Pharmacokinetics, pharmacodynamics and safety of DEB025/alisporivir in combination with ribavirin therapy in chronic hepatitis C genotype 2 and 3 patients who have previously failed interferon therapy or are intolerant or unable to take interferon
• Scientific title: A multicenter, open-label, randomized, 2-arm, phase II trial of pharmacodynamics, pharmacokinetics and safety of two dose regimens of DEB025/alisporivir in combination with ribavirin therapy in chronic hepatitis C genotype 2 and 3 patients who have previously failed interferon therapy or are intolerant or unable to take interferon.
• Date of first enrolment: 27/03/2014
• Target sample size: 60
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003751-38
• 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: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

France, United States

Contacts

• Name: Département ICM
• Affiliation: Novartis Pharma SAS

• Name: Département ICM
• Affiliation: Novartis Pharma SAS

Key inclusion & exclusion criteria

Inclusion criteria:
1. Written informed consent must be obtained before any assessment is performed;
2. HCV G2/3 patients who previously failed a course of interferon based therapy or were intolerant of interferon or are unable to take interferon based on the presence of a contraindication as defined by the label of pegIFN (Pegasys and/or PegIntron);
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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: 18.0 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-

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: equal
Concentration number: 100-

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: equal
Concentration number: 200-

Primary Outcome(s)

Secondary Objective: To evaluate the efficacy among 2 treatment groups with different doses of DEB025 in combination with RBV

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 hypertension (SBP =160 mm Hg or DBP =100 mm Hg)
• changes in platelet count from baseline through week 12.

Main Objective: To evaluate pharmacodynamics, pharmacokinetic between 2 treatment groups receiving different doses of DEB025 in combination with RBV

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

Secondary Outcome(s)

Secondary end point(s): HCV RNA viral load SVR4 and SVR12

Timepoint(s) of evaluation of this end point: post-treatment week 4 and week 12

Secondary ID(s)

CDEB025A2233

Source(s) of Monetary Support

Novartis Pharma Services AG

Ethics review

Status: Approved
Approval date: 07/01/2014
Contact:

Results

• Results available: Yes
• Date Posted: 07/05/2016
• Date Completed: 21/04/2015
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003751-38/results