Chronic Hepatitis CPhase 2NCT00759200
Safety and Efficacy of Albumin Interferon Administered Every 4 Weeks in Genotype 2/3 Hepatitis C Patients
A Phase 2 study testing alb-interferon alfa 2b and peg-interferon in people with Chronic Hepatitis C, run by Novartis at 55 sites in 12 countries.
Trial summary
This study will evaluate the safety and efficacy of alb-interferon in adults with genotype 2 or 3 chronic hepatitis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- alb-interferon alfa 2b and peg-interferon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 525 participants
- Where
- 55 sitesin 12 countries
- Study dates
- Oct 2008to Dec 2010
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18 years or older
- Clinical diagnosis of chronic hepatitis C
- Infection with HCV genotype 2 or 3
- No previous IFNα-based therapy
Who cannot join
- Women of child-bearing potential if not using double barrier method of contraception, pregnant or nursing
- Fertile males, unless condom with spermicide is used and female partner agrees to use one or more of the acceptable methods until 7 months after last dose of RBV
- History or current evidence of decompensated liver disease; other forms of liver disease
- Coinfection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- History of moderate, severe or uncontrolled psychiatric disease
- History of seizure disorder
Show all 20Show fewer
- History or clinical evidence of chronic cardiac disease, preexisting interstitial lung disease or severe lung disease
- Clinically significant findings on eye/retinal examination
- History of immunologically mediated disease
- Organ transplantation other than cornea or hair transplant
- History of clinically significant hemoglobinopathy
- Diagnosis of malignancy of any organ system with the exception of localized basal cell carcinoma of the skin
- History of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
- Drug or alcohol addiction within the last 6 months and/or positive drug screening tests
- Received systemic corticosteroids (prednisone equivalent of > 10 mg/day) within 14 days prior to Baseline visit
- Received concomitant systemic antibiotics, antifungals or antivirals for the treatment of active infection within 14 days prior to Baseline visit.
- Received herbal therapies (including milk thistle or glycyrrhizin) or an investigational drug within 35 days prior to Baseline visit
- Have a clinically significant laboratory abnormality
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
55 sites in 12 countries.
55 sites in 12 countries
Italy7 sites
Novartis Investigative site
Bologna
Novartis Investigative site
Milan
Novartis Investigative site
Naples
Novartis Investigative site
Pavia
Novartis Investigative site
Pisa
Novartis Investigative site
Polermo
Novartis Investigative site
Torino
Australia6 sites
Novartis Investigative site
Clayton
Novartis Investigative site
Fitzroy
Novartis Investigative site
Greenslopes
Novartis Investigative site
Kingswood
Novartis Investigative site
Melbourne
Novartis Investigative site
Westmead
Germany6 sites
Novartis Investigative Site
Berlin
Novartis Investigative Site
Cologne
Novartis Investigative site
Düsseldorf
Novartis Investigative Site
Essen
Novartis Investigative Site
Freiburg im Breisgau
Novartis Investigative Site
Hamburg
India6 sites
Novartis Investigative Site
Chandigarh
Novartis Investigative site
Hyderabad
Novartis Investigative Site
Lucknow
Novartis Investigative Site
Ludhiana
Novartis Investigative Site
Mumbai
Novartis Investigative Site
New Delhi
Spain6 sites
Novartis Investigative site
Barcelona
Novartis Investigative site
Madrid
Novartis Investigative site
Málaga
Novartis Investigative site
Oviedo
Novartis Investigative site
Seville
Novartis Investigative site
Valencia
Canada5 sites
Novartis Investigative site
Calgary
Novartis Investigative Site
Downsview
Novartis Investigative site
Montreal
Novartis Investigative site
Toronto
Novartis Investigative site
Vancouver
Greece5 sites
Novartis Investigative Site
Heraklion
Novartis Investigative Site
Loannina
Novartis Investigative Site
Patra-Rio
Novartis Investigative Site
Piraeurs
Novartis Investigative Site
Thessaloniki
France4 sites
Novartis Investigative Site
Cretail
Novartis Investigative Site
Nice
Novartis Investigative Site
Paris
Novartis Investigative Site
Villejuif
Thailand4 sites
Novartis Investigative site
Bangkok
Novartis Investigative site
Chaingmai
Novartis Investigative Site
Hat Yai
Novartis Investigative Site
Muang
Taiwan3 sites
Novartis Investigative site
Kaohsiung City
Novartis Investigative site
Tainan
Novartis Investigative site
Taipei
Poland2 sites
Novartis Investigative site
Bialystok
Novartis Investigative site
Lodz
About this study
Official title: An Open-label, Randomized, Multicenter, Active-controlled, Dose-ranging Study to Evaluate the Safety and Efficacy of Albinterferon Alfa 2b Administered Every 4 Weeks Plus Ribavirin in Interferon Alfa-naïve Patients With Genotype 2/3 Chronic Hepatitis C
This study will evaluate the safety and efficacy of alb-interferon in adults with genotype 2 or 3 chronic hepatitis
- Conditions
- Chronic Hepatitis C
- Being tested
- alb-interferon alfa 2b, peg-interferon
- Keywords
- Chronic hepatitis C, genotype 2, genotype 3, albumin interferon alfa-2b, alb-interferon
- 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.
alb-interferon alfa 2bDrug
Also called ABF656
900 mcg every 4 weeks
alb-interferon alfa 2bDrug
Also called ABF656
1200 mcg every 4 weeks
alb-interferon alfa 2bDrug
Also called ABF656
1500 mcg every 4 weeks
alb-interferon alfa 2bDrug
Also called ABF656
1800 mcg every 4 weeks
peg-interferonDrug
Also called peg-IFN
Peg-interferon alfa 2a: 180 mcg 1x per wk.
| Study group | Role | What they receive |
|---|---|---|
| alb-interferon arm 1 | Experimental | Not described Receives: Drug: alb-interferon alfa 2b |
| alb-interferon arm 2 | Experimental | Not described Receives: Drug: alb-interferon alfa 2b |
| alb-interferon arm 3 | Experimental | Not described Receives: Drug: alb-interferon alfa 2b |
| alb-interferon arm 4 | Experimental | Not described Receives: Drug: alb-interferon alfa 2b |
| peg-interferon | Active comparator | Not described Receives: Drug: peg-interferon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: at every visit
Secondary outcomes (1)
Viral load
Measured: at weeks 4, 12 and 24 of treatment and 24 weeks post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 525 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Human Genome Sciences Inc.
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00759200
- Sponsor's protocol ID
- CABF656B2202
- Status last verified
- Apr 2011
- First submitted
- 23 Sep 2008
- Last updated
- 16 Nov 2016
- Results posted
- No
Publications
Pianko S, Zeuzem S, Chuang WL, Foster GR, Sarin SK, Flisiak R, Lee CM, Andreone P, Piratvisuth T, Shah S, Sood A, George J, Gould M, Komolmit P, Thongsawat S, Tanwandee T, Rasenack J, Li Y, Pang M, Yin Y, Feutren G, Jacobson IM; B2202 Study Team. Randomized trial of albinterferon alfa-2b every 4 weeks for chronic hepatitis C virus genotype 2/3. J Viral Hepat. 2012 Sep;19(9):623-34. doi: 10.1111/j.1365-2893.2012.01586.x. Epub 2012 Mar 21.
PubMed 22863266
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Multicenter, Active-controlled, Dose-ranging Study to Evaluate the Safety and Efficacy of Albinterferon Alfa 2b Administered Every 4 Weeks Plus Ribavirin in Interferon Alfa-naïve Patients With Genotype 2/3 Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT00759200
- Acronym / sponsor ID
- CABF656B2202
- Conditions
- Chronic Hepatitis C
- Keywords
- Chronic hepatitis C, genotype 2, genotype 3, albumin interferon alfa-2b, alb-interferon
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 525 participants (estimated)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Collaborators
- Human Genome Sciences Inc.
- Study start
- Oct 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 25 Sep 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 the safety and efficacy of alb-interferon in adults with genotype 2 or 3 chronic hepatitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| alb-interferon arm 1 | Experimental | Drug: alb-interferon alfa 2b |
| alb-interferon arm 2 | Experimental | Drug: alb-interferon alfa 2b |
| alb-interferon arm 3 | Experimental | Drug: alb-interferon alfa 2b |
| alb-interferon arm 4 | Experimental | Drug: alb-interferon alfa 2b |
| peg-interferon | Active comparator | Drug: peg-interferon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age of 18 years or older
- Clinical diagnosis of chronic hepatitis C
- Infection with HCV genotype 2 or 3
- No previous IFNα-based therapy
Key exclusion criteria (20 listed)
- Women of child-bearing potential if not using double barrier method of contraception, pregnant or nursing
- Fertile males, unless condom with spermicide is used and female partner agrees to use one or more of the acceptable methods until 7 months after last dose of RBV
- History or current evidence of decompensated liver disease; other forms of liver disease
- Coinfection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- History of moderate, severe or uncontrolled psychiatric 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 |
|---|---|---|
| alb-interferon alfa 2bAlso: ABF656900 mcg every 4 weeks | Drug | alb-interferon arm 1 |
| alb-interferon alfa 2bAlso: ABF6561200 mcg every 4 weeks | Drug | alb-interferon arm 2 |
| alb-interferon alfa 2bAlso: ABF6561500 mcg every 4 weeks | Drug | alb-interferon arm 3 |
| alb-interferon alfa 2bAlso: ABF6561800 mcg every 4 weeks | Drug | alb-interferon arm 4 |
| peg-interferonAlso: peg-IFNPeg-interferon alfa 2a: 180 mcg 1x per wk. | Drug | peg-interferon |
Primary outcome
Adverse events
Time frame: at every visit
1 secondary outcome
Viral load
Time frame: at weeks 4, 12 and 24 of treatment and 24 weeks post-treatment.
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 16 Nov 2016.
- Results publication: PubMed 22863266Pianko S, Zeuzem S, Chuang WL, Foster GR, Sarin SK, Flisiak R, Lee CM, Andreone P, Piratvisuth T, Shah S, Sood A, George J, Gould M, Komolmit P, Thongsawat S, Tanwandee T, Rasenack J, Li Y, Pang M, Yin Y, Feutren G, Jacobson IM; B2202 Study Team. Randomized trial of albinterferon alfa-2b every 4 weeks for chronic hepatitis C virus genotype 2/3. J Viral Hepat. 2012 Sep;19(9):623-34. doi: 10.1111/j.1365-2893.2012.01586.x. Epub 2012 Mar 21.
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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
55 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing alb-interferon alfa 2b and peg-interferon in people with Chronic Hepatitis C, run by Novartis at 55 sites in 12 countries.
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 4 inclusion and 20 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 16 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in Italy, Australia, Germany, India, Spain and 7 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Adverse events (time frame: at every visit). 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 NCT00759200, which also lists 1 linked publication.
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 16 Nov 2016.