Efficacy and Safety of DEB025 Combined With Peg-IFN Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Relapsers and Non-responders

Hepatitis C Chronic Clinical Trial

Official title:

A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Study on Efficacy and Safety of DEB025 Combined With Peg-IFN Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Relapsers and Non-responders to Previous Peg-IFN Alfa-2 Plus Ribavirin Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01183169
• Other study ID #: CDEB025A2210
• Secondary ID: 2010-020033-14
• Status: Completed
• Phase: Phase 2
• First received: August 16, 2010
• Last updated: April 1, 2016
• Start date: August 2010
• Est. completion date: May 2013

Study information

• Verified date: April 2016
• Source: Debiopharm International SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyItaly: Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Medicines AgencySpain: Spanish Agency of MedicinesTaiwan: Department of HealthTurkey: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The study is to investigate whether HCV GT1 patients with a history of non-response/relapse to PegIFN + RBV benefit from treatment with triple therapy of DEB025 plus Peg-IFN and ribavirin compared to triple treatment with placebo matching DEB025 plus Peg-IFN and ribavirin

Recruitment information / eligibility

• Status: Completed
• Enrollment: 459
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion criteria:

Chronic hepatitis C G1 viral infection; Plasma HCV RNA level lower limit = 1,000 IU/ml assessed by qPCR (quantitative polymerase chain reaction) or equivalent at screening, no upper limit; HCV genotype 1; Previous non-responders/relapsers to PegIFN + RBV after treatment for at least 12 weeks.

Exclusion criteria:

Treatment with any anti-HCV drug (whether approved or investigational) within 3 months prior to screening; Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, UNLESS they are using a highly effective contraception; Any other cause of relevant liver disease other than HCV; Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Chronic
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• DEB025 600 mg QD + PegIFN + RBV
DEB025 600 mg QD + peg-IFNa2a once weekly + RBV BID
• DEB025 800 mg QD + PegIFN + RBV
DEB025 800 mg QD + peg-IFNa2a once weekly + RBV BID
• placebo + PegIFN + RBV
Patients will change to active treatment if cEVR not reached), with delayed onset of DEB025 600 mg QD + PegIFN + RBV treatment due to non-response to placebo + PegIFN + RBV)
• placebo + PegIFN + RBV
Patients will change to active treatment if cEVR not reached), with delayed onset of DEB025 400 mg BID + PegIFN + RBV treatment due to non-response to placebo + PegIFN + RBV)
• DEB025 400 mg BID + PegIFN + RBV
DEB025 400 mg BID + peg-IFNa2a once weekly + RBV BID

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Clayton	Victoria
Australia	Novartis Investigative Site	Fitzroy	Victoria
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	Leuven
France	Novartis Investigative Site	Nice Cedex 3
France	Novartis Investigative Site	Paris
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Köln
Germany	Novartis Investigative Site	Leipzig
Hungary	Novartis Investigative Site	Bekescsaba
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Debrecen
Hungary	Novartis Investigative Site	Kaposvár
Hungary	Novartis Investigative Site	Szekesfehervar
Italy	Novartis Investigative Site	Antella - Bagno a Ripoli	FI
Italy	Novartis Investigative Site	Bologna
Italy	Novartis Investigative Site	Padova	PD
Italy	Novartis Investigative Site	Palermo	PA
Italy	Novartis Investigative Site	Parma	PR
Italy	Novartis Investigative Site	Roma	RM
Poland	Novartis Investigative Site	Bialystok
Poland	Novartis Investigative Site	Lódz
Poland	Novartis Investigative Site	Warszawa
Puerto Rico	Novartis Investigative Site	San Juan
Romania	Novartis Investigative Site	Bucharest	District 1
Romania	Novartis Investigative Site	Bucharest	District 3
Romania	Novartis Investigative Site	Bucharest
Romania	Novartis Investigative Site	Bucharest
Romania	Novartis Investigative Site	Iasi
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Majadahonda	Madrid
Spain	Novartis Investigative Site	Sevilla	Andalucia
Taiwan	Novartis Investigative Site	Kaohsiung
Taiwan	Novartis Investigative Site	Keelung City
Taiwan	Novartis Investigative Site	Lin-Ko
Taiwan	Novartis Investigative Site	Niaosong Township
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei	Taiwan, ROC
Taiwan	Novartis Investigative Site	Yun-Lin
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Fatih / Istanbul
Turkey	Novartis Investigative Site	Izmir
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Nottingham
United States	Novartis Investigative Site	Arlington	Texas
United States	Novartis Investigative Site	Bradenton	Florida
United States	Novartis Investigative Site	Brooklyn	New York
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Egg Harbor Twp	New Jersey
United States	Novartis Investigative Site	Honolulu	Hawaii
United States	Novartis Investigative Site	Honolulu	Hawaii
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	Orlando	Florida
United States	Novartis Investigative Site	San Antonio	Texas
United States	Novartis Investigative Site	San Diego	California
United States	Novartis Investigative Site	San Diego	California
United States	Novartis Investigative Site	Springfield	Illinois
United States	Novartis Investigative Site	Springfield	Massachusetts
United States	Novartis Investigative Site	Tampa	Florida
United States	Novartis Investigative Site	Topeka	Kansas
United States	Novartis Investigative Site	Ventura	California

Sponsors (1)

Lead Sponsor	Collaborator
Debiopharm International SA

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France,  Germany,  Hungary,  Italy,  Poland,  Puerto Rico,  Romania,  Spain,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cEVR (complete early virologic response) i.e. HCV RNA < 25 IU/mL (by Limit of Quantitation, LOQ) ; the primary efficacy comparison is between DEB025 active plus peg-IFNa2a once weekly + RBV BID and DEB025 placebo plus peg-IFNa2a once weekly + RBV BID		12 weeks	No
Secondary	SVR12: sustained virologic response 12 weeks following cessation of therapy, defined as HCV RNA negative (by LOQ)		12 weeks post treatment	No
Secondary	cEVR after 12 week triple therapy with 600 mg DEB025 daily plus peg-IFNa2a once weekly + RBV BID versus 800 mg daily plus peg-IFNa2a once weekly + RBV BID versus 400 mg BID plus peg-IFNa2a once weekly + RBV BID.		12 weeks	No