Efficacy and Safety of DEB025 Alone or Combined With Either Ribavirin or Peg-IFN α2a in Chronic Hepatitis C Genotype 2 and 3 naïve Patients

Chronic Pain Clinical Trial

Official title:

A Multicenter, Randomized, Open Label, Parallel-group Phase IIB Study on the Efficacy and Safety of Oral Regimens of DEB025 Alone or in Combination With Ribavirin Versus Standard of Care (Peg-IFNα2a Plus Ribavirin) in Treatment-naïve Hepatitis C Genotype 2 and 3 Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01215643
• Other study ID #: CDEB025A2211
• Secondary ID: 2010-020034-26
• Status: Completed
• Phase: Phase 2
• First received: October 5, 2010
• Last updated: April 1, 2016
• Start date: October 2010
• Est. completion date: May 2012

Study information

• Verified date: April 2016
• Source: Debiopharm International SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesIndia: Ministry of HealthItaly: Ministry of HealthSouth Korea: Korea Food and Drug Administration (KFDA)Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsTaiwan: Department of HealthThailand: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The study is to investigate whether DEB025 alone or in combination with either ribavirin or peg-IFNα2a is more efficient compared to SOC in treatment-naïve patients with HCV genotype 2 and 3. In addition, triple therapy with DEB025 plus SOC will be applied to patients not achieving RVR in the different arms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion criteria:

• Chronic hepatitis C viral

• Plasma HCV RNA level lower limit = 10000 IU/ml assessed by qPCR (quantitative polymerase chain reaction) or equivalent at screening; no upper limit;

• HCV genotype 2 or 3;

• No previous treatment for Hepatitis C infection

Exclusion criteria:

• Patients with evidence of Cirrhosis at the time of screening.

• Patients with evidence of Hepatocellular carcinoma at the time of screening.

• Any other cause of relevant liver disease other than HCV.

• ALT = 10 times ULN.

• Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• DEB025 1000 mg QD
1000 mg QD
• DEB025 600 mg QD + RBV 400 mg BID
400 mg BID
• DEB025 800 mg QD + RBV 400 mg BID
400 mg BID
• DEB025 600 mg QD + peg-IFNa2a once weekly
IFNa2a once weekly
• SOC (peg-IFNa2a once weekly + RBV 400 mg BID)
SOC (peg-IFNa2a once weekly + RBV 400 mg BID)

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Clayton	Victoria
Australia	Novartis Investigative Site	Fitzroy	Victoria
Australia	Novartis Investigative Center	Greenslopes	Queensland
Australia	Novartis Investigative Site	Kingswood	New South Wales
Australia	Novartis Investigative Site	Kogarah	New South Wales
Australia	Novartis Investigative Site	Westmead	New South Wales
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Gent
Belgium	Novartis Investigative Site	Leuven
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Vancouver	British Columbia
France	Novartis Investigative Site	Clichy Cedex
France	Novartis Investigative Site	Creteil
France	Novartis Investigative Site	Marseille
France	Novartis Investigative Site	Paris
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Leipzig
India	Novartis Investigative Site	Guwahati
India	Novartis Investigative Site	Haryana
India	Novartis Investigative Site	Hyderabad - Andhra Pradesh
India	Novartis Investigative Site	Lucknow	Uttar Pradesh
India	Novartis Investigative Site	Ludhiana	Punjab
India	Novartis Investigative Site	Mumbai
India	Novartis Investigative Site	Mumbai	Maharashtra
India	Novartis Investigative Site	New Delhi
India	Novartis Investigative Site	Trivandrum	Kerala
Italy	Novartis Investigative Site	Bologna
Italy	Novartis Investigative Site	Brescia
Italy	Novartis Investigative Site	Pavia
Italy	Novartis Inestigative Site	Roma
Italy	Novartis Investigative Site	Torino
Korea, Republic of	Novartis Inestigative Center	Pusan
Korea, Republic of	Novartis Investigative Site	Pusan
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Korea Ltd.	Seoul
Poland	Novartis Investigative Site	Bialystok
Poland	Novartis Investigative Site	Lódz
Poland	Novartis Investigative Site	Warsaw
Puerto Rico	Fundacion de Investigacion de Diego	San Juan
Taiwan	Novartis Investigative Site	Kaohsiung
Taiwan	Novartis Investigative Site	Niaosong Township
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Yun-Lin
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Chiang Mai
Thailand	Novartis Investigative Site	Songkla
United Kingdom	Novartis Investigative Site	Glasgow - Scotland
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Plymouth
United States	The North Texas Research Institute	Arlington	Texas
United States	Hawai Medical Center East LLC	Honolulu	Hawaii
United States	Liver Associates of Texas	Houston	Texas
United States	Liver Specialist of Texas	Houston	Texas
United States	Scripps Clinic	La Jolla	California
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Columbia University Medical Center	New York	New York
United States	Mount Sinai Medical Center	New York	New York
United States	Weill Cornell Medical Center	New York	New York
United States	Alamo Medical Research	San Antonio	Texas
United States	Research and Education Inc.	San Diego	California
United States	Sharp Rees-Stealy Medical Group, Inc.	San Diego	California
United States	The Office of Dr. Claudia Martorell	Springfield	Massachusetts
United States	Saint Louis University	St. Louis	Missouri
United States	Cotton O'Neil Clinical Research	Topeka	Kansas
United States	Island View Gastroenterology Associates	Ventura	California

Sponsors (1)

Lead Sponsor	Collaborator
Debiopharm International SA

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Germany,  India,  Italy,  Korea, Republic of,  Poland,  Puerto Rico,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure: RVR : Rapid Viral Response : defined as serum HCV RNA undetectable (by LOQ) after 4 weeks of treatment.		4 weeks	No
Secondary	Measure: SVR24 : Sustained Viral Response Week 24 : defined as serum HCV RNA undetectable (by LOD) after 24 weeks of treatment.		24 weeks	No