HDV-Interferon in the Treatment of Chronic Hepatitis C Nonresponders and Naive Hepatitis C Patients

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2009 by Hepasome Pharmaceuticals.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Hepasome Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00703872

First received: June 23, 2008

Last updated: January 8, 2009

Last verified: January 2009

History of Changes

Purpose

A Phase II, Open Label, Multi-Center, Proof-Of-Concept Study determing whether treatment with HDV-Interferon (HDV-IFN), by oral or subcutaneous (injection) routes, and ribavirin results in similar efficacy [Rapid Virologic Response (RVR)] and safety as the reported efficacy and safety with pegylated alpha-interferon-2a and ribavirin (historical control) in patients with chronic hepatitis C (treatment naïve by oral route and non-responders by SC route respectively).

Condition	Intervention	Phase
Chronic Hepatitis C	Drug: Oral HDV-Interferon + ribavarin Drug: Injectable HDV-Interferon + ribavarin	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Evaluation of Two Dose Routes of HDV-Interferon Administered With Ribavarin in the Treatment of Chronic Hepatitis C Nonresponders and Naive Hepatitis C Patients

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Interferon

U.S. FDA Resources

Further study details as provided by Hepasome Pharmaceuticals:

Primary Outcome Measures:

Rapid Virologic Response [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Early Virologic Response [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Sustained Virologic Response [ Time Frame: 24 weeks post-treatment ] [ Designated as safety issue: No ]


Estimated Enrollment:	50
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Oral HDV-Interferon	Drug: Oral HDV-Interferon + ribavarin Naive pateints
Experimental: 2 Injectable HDV-Interferon + ribavarin	Drug: Injectable HDV-Interferon + ribavarin Nonresponders

Detailed Description:

Part 1 ("initial part") - 4 weeks of treatment (28 days):

All patients will complete an initial 4 weeks of treatment with HDV-Interferon (HDV-IFN) (treatment naïve by oral route and non-responders by SC route respectively) and ribavirin.
The Part 1 of the study shall assess whether a 4-week treatment course with HDV-Interferon (HDV-IFN), orally or by subcutaneous injection, and ribavirin results similar efficacy [Rapid Virologic Response (RVR)] and safety as the reported efficacy and safety with pegylated alpha-interferon-2a and ribavirin (historical control) in patients with chronic hepatitis C (treatment naïve and non-responders).

Part 2 ("continuation part") - 44 or 20 weeks of treatment + 24 weeks (follow-up period):

Patients with hepatitis C viral genotype 1, who achieve RVR, will be treated for another 44 weeks of therapy (to complete 48 weeks of active treatment) followed by 24 weeks of treatment-free follow-up period.
Patients with hepatitis C viral genotype 3, who achieve RVR, will be treated for another 20 weeks of therapy (to complete 24 weeks of active treatment) followed by 24 weeks of treatment-free follow-up period.
Follow-up period (24 weeks): Thus, in addition to treatment in Part 1 of study, each completed patient with viral genotype 1 will receive 44 weeks of therapy and 24 weeks of treatment-free follow-up; and viral genotype 3 patients will have 20 weeks of therapy & 24 weeks of treatment study drug free follow-up.
Overall study duration (72 or 48 weeks): Patients with viral genotype 1 will have an overall study duration of 72 weeks (48 weeks of therapy plus 24 weeks follow-up) and patients with viral genotype 3 will have an overall study duration of 48 weeks (24 weeks of therapy plus 24 weeks follow-up).

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria - Nonresponders:

Patients >18 years with established chronic hepatitis C with viral genotype 1 or viral genotype 3 who have failed to respond to at least a 3-month course of a pegylated interferon alpha 2a + ribavirin and have a detectable HCV RNA and baseline liver biopsy available from within the prior 12 months.

Inclusion Criteria - Naive:

Treatment naïve patients > 18 years, inclusive, are eligible for this study.
Patients will be viral genotype 1 or viral genotype 3, have quantifiable HCV-RNA > 1000 IU/mL as demonstrated by PCR and an abnormal ALT (within 6 months of screening) and compensated liver disease with or without cirrhosis.

Exclusion Criteria - Nonresponders:

Patients with decompensated cirrhosis or other forms of liver disease
Hb < 10g/dL for males & Hb < 9 g/dl for females
hepatocellular carcinoma
active hepatitis B infection
human immunodeficiency virus (HIV)
pre-existing severe or uncontrolled depression or other psychiatric disease
significant cardiac disease
renal disease
seizure disorders or retinopathy

Exclusion Criteria - Nonresponders:

Patients with decompensated cirrhosis or other forms of liver disease
Hb < 10g/dL for males & Hb < 9 g/dl for females
hepatocellular carcinoma
active hepatitis B infection
HIV
pre-existing severe or uncontrolled depression or other psychiatric disease - significant cardiac disease
renal disease
seizure disorders or retinopathy

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00703872

Locations


India
Global Hospitals
Lakdi-ka-Pool, Hyderabad, India, 500 004

Sponsors and Collaborators

Hepasome Pharmaceuticals

Investigators


Principal Investigator:	Dharmesh Kapoor, MD	Global Hospitals, Lakdi-ka-pool, Hyderabad - 500 004 India

More Information


Responsible Party:	Len Rosenberg, PhD, RPh, Hepasome Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00703872 History of Changes
Other Study ID Numbers:	HP 01-2006-01
Study First Received:	June 23, 2008
Last Updated:	January 8, 2009
Health Authority:	India: Drugs Controller General of India

Keywords provided by Hepasome Pharmaceuticals:


Chronic Hepatitis C Naive Nonresponders Interferon Patients with Chronic Hepatitis C

Additional relevant MeSH terms:


Hepatitis, Chronic Hepatitis Hepatitis A Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases	Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Interferons Antineoplastic Agents Antiviral Agents Anti-Infective Agents

ClinicalTrials.gov processed this record on September 23, 2016

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