Hepatitis BNCT03123653
To Study the Efficacy of PEG-IFN Alpha in HBeAg Negative Chronic Hepatitis B Patients After Stopping Nucleotide Analogue Therapy.
A study testing Peg IFN 2b in people with Hepatitis B, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Study population:Person with HBeAg negative CHB on TDF/ETV for more than 1 year Study design:Prospective,Interventional (single arm study) Sample size: All the patients fulfilling the inclusion criteria will be included in first 6 months and subsequently followed up for 2 years Intervention: Peg IFN 2b 1.5mcg/kg once… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Peg IFN 2b
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteIndia
- Study dates
- 17 Mar 2017to 17 Sep 2020
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HBeAg negative Chronic HBV infection who are having HBV DNA-undetectable. ALT <40 IU/ml No Advanced fibrosis[LSM <14 KPa] TDF/ETV >1 year Clinical Relapse after stopping NA will be defined as HBV DNA>2000IU/ml and ALT > 80IU
Who cannot join
- HBeAg+ CHB Pregnancy Cirrhosis on biopsy or LSM >14 Co-infection- HIV/HCV/HDV Immunosuppressive therapy Renal failure S.Bilirubin>2mg/dl Patient having neutropenia
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: To Study the Efficacy of PEG-IFN Alpha in HBeAg Negative Chronic Hepatitis B Patients After Stopping Nucleotide Analogue Therapy
- Study population:Person with HBeAg negative CHB on TDF/ETV for more than 1 year
- Study design:Prospective,Interventional (single arm study)
- Sample size: All the patients fulfilling the inclusion criteria will be included in first 6 months and subsequently followed up for 2 years
- Intervention: Peg IFN 2b 1.5mcg/kg once every week for 48 weeks
- Monitoring and assessment: LFT,HBV DNA and HbsAg at baseline, 4 weeks, 12 weeks,24 weeks,48 weeks ,72 weeks and 96 weeks, CBC every month and Thyroid function Test every 3rd month
- Adverse effects: The most frequently reported side effects of IFN-based therapy are flu-like symptoms, headache, fatigue, myalgia, alopecia, and local reaction at the injection site. Peg-IFN have myelosuppressive effects; however, neutropenia\1000/mm3 and thrombocytopenia \500,000/ mm3 are not common unless patients already have cirrhosis
- Conditions
- Hepatitis B
- Being tested
- Peg IFN 2b
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peg IFN 2bDrug
Peg IFN 2b 1.5mcg/kg once every week for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Peg IFN 2b | Experimental | Peg IFN 2b 1.5mcg/kg once every week for 48 weeks. Receives: Drug: Peg IFN 2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Virological Response-HBV DNA<2000IU/ml after stopping PEG IFN alpha
Measured: 6 months
Secondary outcomes (3)
Loss of HBsAg after 48 weeks of PEG IFN alpha
Measured: 48 weeks
End treatment Response: HBV-DNA -undetectable after 48 weeks of PEG-IFN
Measured: 48 weeks
Sustained Off treatment Virological response defined as No clinical relapse during 1 year follow up after stopping therapy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start17 Mar 2017
- Primary completion17 Sep 2019
- Study completion17 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03123653
- Sponsor's protocol ID
- ILBS-HBV-01
- Status last verified
- Oct 2019
- First submitted
- 19 Apr 2017
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study the Efficacy of PEG-IFN Alpha in HBeAg Negative Chronic Hepatitis B Patients After Stopping Nucleotide Analogue Therapy
- ClinicalTrials.gov ID
- NCT03123653
- Acronym / sponsor ID
- ILBS-HBV-01
- Conditions
- Hepatitis B
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 17 Mar 2017 (actual)
- Primary completion
- 17 Sep 2019 (actual)
- Study completion
- 17 Sep 2020 (estimated)
- First posted
- 21 Apr 2017 (actual)
- 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.
- Study population:Person with HBeAg negative CHB on TDF/ETV for more than 1 year
- Study design:Prospective,Interventional (single arm study)
- Sample size: All the patients fulfilling the inclusion criteria will be included in first 6 months and subsequently followed up for 2 years
- Intervention: Peg IFN 2b 1.5mcg/kg once every week for 48 weeks
- Monitoring and assessment: LFT,HBV DNA and HbsAg at baseline, 4 weeks, 12 weeks,24 weeks,48 weeks ,72 weeks and 96 weeks, CBC every month and Thyroid function Test every 3rd month
- Adverse effects: The most frequently reported side effects of IFN-based therapy are flu-like symptoms, headache, fatigue, myalgia, alopecia, and local reaction at the injection site. Peg-IFN have myelosuppressive effects; however, neutropenia\1000/mm3 and thrombocytopenia \500,000/ mm3 are not common unless patients already have cirrhosis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peg IFN 2b | Experimental | Drug: Peg IFN 2bPeg IFN 2b 1.5mcg/kg once every week for 48 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- HBeAg negative Chronic HBV infection who are having HBV DNA-undetectable. ALT <40 IU/ml No Advanced fibrosis[LSM <14 KPa] TDF/ETV >1 year Clinical Relapse after stopping NA will be defined as HBV DNA>2000IU/ml and ALT > 80IU
Key exclusion criteria (1 listed)
- HBeAg+ CHB Pregnancy Cirrhosis on biopsy or LSM >14 Co-infection- HIV/HCV/HDV Immunosuppressive therapy Renal failure S.Bilirubin>2mg/dl Patient having neutropenia
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 |
|---|---|---|
| Peg IFN 2bPeg IFN 2b 1.5mcg/kg once every week for 48 weeks | Drug | Peg IFN 2b |
Primary outcome
Sustained Virological Response-HBV DNA<2000IU/ml after stopping PEG IFN alpha
Time frame: 6 months
3 secondary outcomes
Loss of HBsAg after 48 weeks of PEG IFN alpha
Time frame: 48 weeks
End treatment Response: HBV-DNA -undetectable after 48 weeks of PEG-IFN
Time frame: 48 weeks
Sustained Off treatment Virological response defined as No clinical relapse during 1 year follow up after stopping therapy
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: No
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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 study testing Peg IFN 2b in people with Hepatitis B, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Feb 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 India. 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.
Are results available for this study?
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?
Sustained Virological Response-HBV DNA<2000IU/ml after stopping PEG IFN alpha (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2020.