Chronic Hepatitis BPhase 1/2NCT00964665
Pharmacokinetic/Pharmacodynamic of Albinterferon Alfa-2b in Chronic Hepatitis B, eAg+, Infection Subjects
A Phase 1/2 study testing albinterferon alfa-2b and Pegasys® in people with Chronic Hepatitis B, run by Novartis Pharmaceuticals at 12 sites in 5 countries.
Trial summary
This study will assess the efficacy of ABF656 in chronic hepatitis B characterized by HBeAg positivity. The study is designed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of Phase 3 trials. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- albinterferon alfa-2b and Pegasys®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 12 sitesin 5 countries
- Study dates
- Jul 2009to Nov 2010
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18-75 years of either non-child bearing potential or if of child bearing potential on two adequate forms of birth control
- Chronic HBV infection (serum HBsAg detectable for > 6 months)
- Serum HBeAg positive with HBV DNA >106copies/mL (or >200,000 IU/mL)
- Serum ALT must be > 2 x ULN but below 10 x ULN
Who cannot join
- Steroid treatment or immunosuppression 3 months prior to entry.
- Chest X-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease.
- Hb< 10g/dL or, and ANC < 750/mm3 or , and platelet count < 75,000 mm3 .
- Significant chronic medical conditions other than chronic hepatitis B which in the opinion of the investigator preclude enrollment into the study.
- Evidence of hepatic decompensation (i.e., Child-Pugh score of B or C).
- Seropositive for HIV, HCV, or HDV (Hepatitis Delta virus).
Show all 9Show fewer
- History of hypothyroidism or current treatment for thyroid disease.
- Patients with treated or untreated malignancy of any organs, with the exception of localized basal cell carcinoma
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
Poland3 sites
Novartis Investigator Site
Bialystok
Novartis Investigator Site
Lodz
Novartis Investigator Site
Warsaw
Taiwan3 sites
Novartis Investigator Site
Kaohsiung City
Novartis Investigator Site
Taipei
Novartis Investigator Site
Tau-Yuan County
Thailand3 sites
Novartis Investigator Site
Bangkok
Novartis Investigator Site
Chiang Mai
Novartis Investigator Site
Songkhla
Hong Kong2 sites
Novartis Investigator Site
Shatin
Novartis Investigator Site
Taipo
About this study
Official title: A Pharmacokinetic/Pharmacodynamic Evaluation of ABF656 in Subjects With Chronic Hepatitis B, e Ag+, Infection.
This study will assess the efficacy of ABF656 in chronic hepatitis B characterized by HBeAg positivity. The study is designed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of Phase 3 trials. The trial is also designed to generate the PK data in hepatitis B patients to satisfy regulatory requirements in China.
- Conditions
- Chronic Hepatitis B
- Being tested
- albinterferon alfa-2b, Pegasys®
- Keywords
- Hepatitis B,, Chronic,, Hepatitis B e Antigens positive
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
albinterferon alfa-2bDrug
albinterferon alfa-2bDrug
albinterferon alfa-2bDrug
albinterferon alfa-2bDrug
Pegasys®Drug
| Study group | Role | What they receive |
|---|---|---|
| Group 1 ABF656 900ug Q2w | Experimental | Not described Receives: Drug: albinterferon alfa-2b |
| Group 2 ABF656 900ug Q4w | Experimental | Not described Receives: Drug: albinterferon alfa-2b |
| Group 3 AB656 1200ug Q4w | Experimental | Not described Receives: Drug: albinterferon alfa-2b |
| Group 4 ABF656 1500ug Q4w | Experimental | Not described Receives: Drug: albinterferon alfa-2b |
| Group 5 Pegasys® 180µg qw | Active comparator | Not described Receives: Drug: Pegasys® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety, tolerability and pharmacodynamic effect of various doses of albinterferon alfa-2b in hepatitis B patients on seroconversion of hepatitis markers. Measure: Clinical laboratory. HBV DNA level and HBeAg seroconversion rate.
Measured: 48 weeks
Secondary outcomes (1)
Evaluate the pharmacokinetics at different doses of albinterferon alfa-2b in patients with chronic hepatitis B infection. Measure: Serum concentration of albinterferon alfa-2b
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Human Genome Sciences Inc.
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Institutes for BioMedical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00964665
- Sponsor's protocol ID
- CABF656A2206
- Other IDs
- EudraCT 2008-006933-29
- Status last verified
- Jan 2011
- First submitted
- 24 Aug 2009
- Last updated
- 6 Jan 2011
- Results posted
- No
Publications
Cooksley WG, Piratvisuth T, Lee SD, Mahachai V, Chao YC, Tanwandee T, Chutaputti A, Chang WY, Zahm FE, Pluck N. Peginterferon alpha-2a (40 kDa): an advance in the treatment of hepatitis B e antigen-positive chronic hepatitis B. J Viral Hepat. 2003 Jul;10(4):298-305. doi: 10.1046/j.1365-2893.2003.00450.x.
PubMed 12823597Colvin RA, Tanwandee T, Piratvisuth T, Thongsawat S, Hui AJ, Zhang H, Ren H, Chen PJ, Chuang WL, Sobhonslidsuk A, Li R, Qi Y, Praestgaard J, Han Y, Xu J, Stein DS; ABF656A2206 Study Group. Randomized, controlled pharmacokinetic and pharmacodynamic evaluation of albinterferon in patients with chronic hepatitis B infection. J Gastroenterol Hepatol. 2015 Jan;30(1):184-91. doi: 10.1111/jgh.12671.
PubMed 24995515
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic/Pharmacodynamic Evaluation of ABF656 in Subjects With Chronic Hepatitis B, e Ag+, Infection.
- ClinicalTrials.gov ID
- NCT00964665
- Acronym / sponsor ID
- CABF656A2206
- Conditions
- Chronic Hepatitis B
- Keywords
- Hepatitis B,, Chronic,, Hepatitis B e Antigens positive
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Human Genome Sciences Inc.
- Study start
- Jul 2009
- Primary completion
- Nov 2010 (actual)
- First posted
- 25 Aug 2009 (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 assess the efficacy of ABF656 in chronic hepatitis B characterized by HBeAg positivity. The study is designed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of Phase 3 trials. The trial is also designed to generate the PK data in hepatitis B patients to satisfy regulatory requirements in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 ABF656 900ug Q2w | Experimental | Drug: albinterferon alfa-2b |
| Group 2 ABF656 900ug Q4w | Experimental | Drug: albinterferon alfa-2b |
| Group 3 AB656 1200ug Q4w | Experimental | Drug: albinterferon alfa-2b |
| Group 4 ABF656 1500ug Q4w | Experimental | Drug: albinterferon alfa-2b |
| Group 5 Pegasys® 180µg qw | Active comparator | Drug: Pegasys® |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, aged 18-75 years of either non-child bearing potential or if of child bearing potential on two adequate forms of birth control
- Chronic HBV infection (serum HBsAg detectable for > 6 months)
- Serum HBeAg positive with HBV DNA >106copies/mL (or >200,000 IU/mL)
- Serum ALT must be > 2 x ULN but below 10 x ULN
Key exclusion criteria (9 listed)
- Steroid treatment or immunosuppression 3 months prior to entry.
- Chest X-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease.
- Hb< 10g/dL or, and ANC < 750/mm3 or , and platelet count < 75,000 mm3 .
- Significant chronic medical conditions other than chronic hepatitis B which in the opinion of the investigator preclude enrollment into the study.
- Evidence of hepatic decompensation (i.e., Child-Pugh score of B or C).
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-2b | Drug | Group 1 ABF656 900ug Q2w |
| albinterferon alfa-2b | Drug | Group 2 ABF656 900ug Q4w |
| albinterferon alfa-2b | Drug | Group 3 AB656 1200ug Q4w |
| albinterferon alfa-2b | Drug | Group 4 ABF656 1500ug Q4w |
| Pegasys® | Drug | Group 5 Pegasys® 180µg qw |
Primary outcome
Evaluate the safety, tolerability and pharmacodynamic effect of various doses of albinterferon alfa-2b in hepatitis B patients on seroconversion of hepatitis markers. Measure: Clinical laboratory. HBV DNA level and HBeAg seroconversion rate.
Time frame: 48 weeks
1 secondary outcome
Evaluate the pharmacokinetics at different doses of albinterferon alfa-2b in patients with chronic hepatitis B infection. Measure: Serum concentration of albinterferon alfa-2b
Time frame: up to 12 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2011.
- Background: PubMed 12823597Cooksley WG, Piratvisuth T, Lee SD, Mahachai V, Chao YC, Tanwandee T, Chutaputti A, Chang WY, Zahm FE, Pluck N. Peginterferon alpha-2a (40 kDa): an advance in the treatment of hepatitis B e antigen-positive chronic hepatitis B. J Viral Hepat. 2003 Jul;10(4):298-305. doi: 10.1046/j.1365-2893.2003.00450.x.
- Derived from this study: PubMed 24995515Colvin RA, Tanwandee T, Piratvisuth T, Thongsawat S, Hui AJ, Zhang H, Ren H, Chen PJ, Chuang WL, Sobhonslidsuk A, Li R, Qi Y, Praestgaard J, Han Y, Xu J, Stein DS; ABF656A2206 Study Group. Randomized, controlled pharmacokinetic and pharmacodynamic evaluation of albinterferon in patients with chronic hepatitis B infection. J Gastroenterol Hepatol. 2015 Jan;30(1):184-91. doi: 10.1111/jgh.12671.
Related trials for Chronic Hepatitis B
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
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 Institutes for BioMedical Research
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing albinterferon alfa-2b and Pegasys® in people with Chronic Hepatitis B, run by Novartis Pharmaceuticals at 12 sites in 5 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 9 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: stopped early, as of the sponsor's last update on 6 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Poland, Taiwan, Thailand, Hong Kong, China. 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 combined 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.
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 was stopped early. Results are not available in the source record.
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?
Evaluate the safety, tolerability and pharmacodynamic effect of various doses of albinterferon alfa-2b in hepatitis B patients on seroconversion of hepatitis markers. Measure: Clinical laboratory. HBV DNA level and HBeAg seroconversion rate. (time frame: 48 weeks). 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 NCT00964665, which also lists 2 linked publications.
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 6 Jan 2011.