- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01121731
A Phase I/II Clinical Trial With Interferon Alfa 5 in Treatment-Experienced Patients With Genotype-1 Chronic Hepatitis C
February 4, 2013 updated by: Digna Biotech S.L.
Phase I/II, Multicenter, Randomized, Open,Active-Controlled, ClinicalTrial to Evaluate PK, PD, Safety and Tolerability Of Interferon Alfa 5, S.C. 3 Times Per Week, For 29 Days, To Treat-Experienced Pat. With Genotype-1 Chronic Hepatitis C
The general aim of this study is to determine if 3 MIU of IFN-α5 in monotherapy, and 1,5 MIU of IFN-α5 combined with 1,5 MIU of IFN- α2b, are safe dose levels as well as to investigate the antiviral efficacy and pharmacodynamics (PD) of such doses and drugs in treatment-experienced HCV patients with genotype 1 chronic infection, after 29 days of treatment.
It is also intended to determine pharmacokinetics (PK) of the safe dose achieved of IFN-α5 in monotherapy.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Phase 2
- 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
-
-
-
A Coruña, Spain
- Centre 013
-
Barcelona, Spain
- Centre 004
-
Barcelona, Spain
- Centre 005
-
Barcelona, Spain
- Centre 008
-
Barcelona, Spain
- Centre 011
-
Granada, Spain
- Centre 014
-
León, Spain
- Centre 015
-
Madrid, Spain
- Centre 002
-
Madrid, Spain
- Centre 003
-
Madrid, Spain
- Centre 006
-
Madrid, Spain
- Centre 009
-
Madrid, Spain
- Centre 016
-
Pamplona, Spain
- Centre 001
-
Santander, Spain
- Centre 012
-
Sevilla, Spain
- Centre 010
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients aged ≥18 years old,
- With chronic hepatitis C (CHC) infection diagnosed by seropositivity for anti-HCV antibodies or detectable HCV-RNA, at least 6 months prior to screening.
- Patients with CHC infection of genotype 1 (1a, 1b or mixed 1a/1b)
- Defined as relapsers: those CHC patients who had achieved virologic response (HCV-RNA non detectable) at any time during the standard care of treatment for CHC with IFN-α2 or PegIFN-α2 + ribavirin, and maintained it trough the end of treatment at week 48 weeks, but HCV-RNA detection occurs before 6 months post-treatment.
- In whom liver cirrhosis has been ruled out through fibro-scan or liver biopsy within 24 months prior to study enrolment.
- With a serum HCV viral load ≥ 100.000 IU/mL at screening
- With alanine-aminotransferase (ALT) and aspartate-aminotransferase (AST) serum measurements at screening less than 5 times of their upper limits of normal (ULN)
- With a body mass index (BMI) of at least 18 kg/m2, but not exceeding 36 kg/m2.
- For female subjects with childbearing potential: use of a known highly effective method of birth control
- For male subjects with partners of child bearing potential: use of appropriate contraceptive methods.
- Is able to effectively communicate with the investigator and other testing center personnel.
- Is able to participate and willing to give written informed consent and comply with the study restrictions.
Exclusion Criteria(principal):
- Hepatitis C infection of genotype 2, 3 or 4 or any mixed genotype (1/2, 1/3 and 1/4).
- A positive ELISA for HIV-1 or HIV-2.
- Hepatitis B virus (HBV) infection based on the presence of HBsAg.
- Hepatitis A virus (HAV) infection based on the presence of antiHAV-IgM. (AM 4)Criteria deleted
- Decompensated liver disease, or history of decompensated liver disease.
- History or other evidence of a medical condition associated with decompensated renal, immunologically mediated, chronic pulmonary, cardiac, thyroid, severe retinopathy, severe psychiatric, organ transplantation, cancer, seizure disorder or pancreatitis diseases.
- An active or suspected malignancy or history of malignancy within the last five years.
- Patients with a documented drug and alcohol addiction free history of at least 12 months who are, in the opinion of the investigator unlikely to relapse, may be enrolled in the study.
- Positive results for drug abuse at screening.Occasional use of cannabis previously to randomization is not an exclusion criteria -under investigator team criteria-. The patient should be advised of abstinence during the trial (AM 6)
- Haemoglobin <12.0g/dL for women, and <13.0g/dL for men at screening.
- White blood cell count <2000 cells/mm3 at screening.
- Absolute neutrophil count <1500 cells/mm3 at screening.
- Platelet count <100.000 cells/mm3 at screening.
- ALT and AST levels ≥ 5 xULN at screening.
- Prothrombin time INR prolonged to 1.5xULN at screening.
- TSH an T4 outside normal limits and not adequately controlled thyroid function at screening.
- Poorly controlled diabetes mellitus as evidenced by HbA1c >7.5% at screening.
- Alfa-fetoprotein value >100ng/mL at screening.
- Total bilirubin >1.5xULN with ratio of direct/indirect >1, at screening unless predominantly conjugated and reflecting Gilbert's disease
- Estimated creatinine clearance of 30 mL/minute or less at screening.
- Women who are confirmed to be pregnant
- People with known hypersensitivity to any ingredient of the investigational agents
- Patients who are at risk of bleeding.
- Haemoglobinopathy
- Screening ECG QTc value ≥ 450ms and/or clinically significant ECG findings.
- History of clinically significant drug allergies.
- Participation in a clinical study with an investigational drug, biologic, or device within 3 months prior to anticipated dose administration.
- Any chronic viral (including HSV), bacterial, mycobacterial, fungal, parasitic, or protozoal infection.
- Requirement for chronic systemic corticosteroids.
- Receiving systemic antivirals, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to enrollment.
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Interferon α-5
|
3 MIU or safe dose used three times a week (TIW) in alternate days in monotherapy.
29 days of treatment.
Subcutaneous injection.
|
Experimental: Interferon α-5 plus Interferon α-2b
|
Interferon-α5 plus Interferon-α 2b.
1.5 MIU each, or safe dose used TIW in alternate days in combined therapy.
29 days of treatment.
Subcutaneous injection.
|
Active Comparator: Interferon α-2b (INTRON® A)
|
3 million IU TIW in alternate days in monotherapy.
29 days of treatment.
Subcutaneous injection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safe dose level
Time Frame: 29 days of treatment
|
PRIMARY ENDPOINTS OF PHASE I
PRIMARY ENDPOINTS OF PHASE II
|
29 days of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pharmacodynamic and pharmacokinetic parameters
Time Frame: 29 days of treatment
|
SECONDARY ENDPOINTS OF PHASE I
SECONDARY ENDPOINTS OF PHASE II
|
29 days of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jesús Prieto, MD, PhD, Clínica Universidad de Navarra. Spain
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
May 1, 2010
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
May 10, 2010
First Submitted That Met QC Criteria
May 10, 2010
First Posted (Estimate)
May 12, 2010
Study Record Updates
Last Update Posted (Estimate)
February 5, 2013
Last Update Submitted That Met QC Criteria
February 4, 2013
Last Verified
February 1, 2013
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
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Interferons
- Interferon alpha-2
Other Study ID Numbers
- NAHE001-CHC-01
- 2009-012924-10 (EudraCT Number)
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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