Chronic Hepatitis CPhase 1NCT00724776

Albinterferon Alfa 2b Single Dose in Japanese Chronic Hepatitis C Patients

A Phase 1 study testing Albinterferon alfa 2b in people with Chronic Hepatitis C, run by Novartis at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of albinterferon alfa 2b (alb-IFN) single dose in Japanese chronic hepatitis C patients Read more about this study

Who is it for?: Ages 20 to 69 years
Conditions the study is for: Chronic Hepatitis C
What is being tested?: Albinterferon alfa 2b
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteJapan
Study dates: Jul 2008to Jul 2009
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 69 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Japan1 site

Novartis Pharmaceuticals, Japan
Tokyo

Other trials in Japan

About this study

Official title: 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

Conditions: Chronic Hepatitis C
Being tested: Albinterferon alfa 2b
Keywords: Chronic hepatitis C, Albinterferon alfa 2b, phase I, Japan
Medical subject headings: Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Albinterferon alfa 2bBiological
recombinant human albumin-interferon alfa fusion protein, 600-1800mcg single dose by S.C. on Day 0

Study groups in NCT00724776
Study group	Role	What they receive
1	Experimental	Open-label treatment with albinterferon alfa 2b escalating single dose Receives: Biological: Albinterferon alfa 2b

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and tolerability after single dose
Measured: 5 weeks after single dose

Secondary outcomes (1)

Pharmacokinetics of albinterferon alfa 2b HCV RNA and ALT as pharmacodynamics evaluation
Measured: 5 weeks after single dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2008Jul 2009

First posted30 Jul 2008 (estimated)
Study startJul 2008
Primary completionJul 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00724776
Sponsor's protocol ID: CABF656A1202
Status last verified: Aug 2010
First submitted: 28 Jul 2008
Last updated: 8 Dec 2020
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

All Chronic Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT00724776
Acronym / sponsor ID: CABF656A1202
Conditions: Chronic Hepatitis C
Keywords: Chronic hepatitis C, Albinterferon alfa 2b, phase I, Japan
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Jul 2008
Primary completion: Jul 2009 (actual)
First posted: 30 Jul 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of albinterferon alfa 2b (alb-IFN) single dose in Japanese chronic hepatitis C patients

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Biological: Albinterferon alfa 2bOpen-label treatment with albinterferon alfa 2b escalating single dose

Who may qualify

Ages: 20 to 69 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Albinterferon alfa 2brecombinant human albumin-interferon alfa fusion protein, 600-1800mcg single dose by S.C. on Day 0	Biological	1

Primary outcome

Safety and tolerability after single dose
Time frame: 5 weeks after single dose

1 secondary outcome

Pharmacokinetics of albinterferon alfa 2b HCV RNA and ALT as pharmacodynamics evaluation
Time frame: 5 weeks after single dose

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
Results for CABF656A1202 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.

Related trials for Chronic Hepatitis C

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Albinterferon alfa 2b in people with Chronic Hepatitis C, run by Novartis at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability after single dose (time frame: 5 weeks after single dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00724776.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.