- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00724776
Albinterferon Alfa 2b Single Dose in Japanese Chronic Hepatitis C Patients
December 6, 2020 updated by: Novartis
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Escalating Single Dose of Albinterferon Alfa 2b (Alb-IFN), Recombinant Human Albumin-interferon Alfa Fusion Protein in Japanese Chronic Hepatitis C Patients.
This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of albinterferon alfa 2b (alb-IFN) single dose in Japanese chronic hepatitis C patients
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tokyo, Japan
- Novartis Pharmaceuticals, Japan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 69 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have a clinical diagnosis of CHC established on the basis of a detectable viral load as measured by a serum HCV RNA test at least 6 months before and during the screening period.
- Age 20 to 69 years
- Have compensated liver disease results on screening laboratory assessment
Exclusion Criteria:
- Evidence of decompensated liver disease and/or liver cirrhosis.
- Body weight < 50 kg.
- A history of immunologically mediated disease.
- A history or other clinical evidence of interstitial lung disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Open-label treatment with albinterferon alfa 2b escalating single dose
|
recombinant human albumin-interferon alfa fusion protein, 600-1800mcg single dose by S.C. on Day 0
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability after single dose
Time Frame: 5 weeks after single dose
|
5 weeks after single dose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics of albinterferon alfa 2b HCV RNA and ALT as pharmacodynamics evaluation
Time Frame: 5 weeks after single dose
|
5 weeks after single dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
July 28, 2008
First Submitted That Met QC Criteria
July 28, 2008
First Posted (Estimate)
July 30, 2008
Study Record Updates
Last Update Posted (Actual)
December 8, 2020
Last Update Submitted That Met QC Criteria
December 6, 2020
Last Verified
August 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis, Chronic
- Hepatitis C, Chronic
Other Study ID Numbers
- CABF656A1202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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