Chronic Hepatitis B InfectionPhase 4NCT05355467
Efficacy and Safety of Ricovir® in Maintaining Durability of Viral Response in Chronic Hepatitis B Patients Who Have Been Treated With Viread® and Have Undetectable HBV DNA in Serum
A Phase 4 study testing Tenofovir disoproxil fumarate and Historical Data in people with Chronic Hepatitis B Infection, run by Mylan (Taiwan) Ltd at 1 site in Taiwan.
Trial summary
This is a phase IV, open label, historical controlled comparative study to evaluate the efficacy and safety of Ricovir® in maintaining durability of viral response in CHB patients who have been treated with Viread® and have undetectable HBV DNA in serum by real-time polymerase chain reaction (PCR) assay. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Hepatitis B Infection
- What is being tested?
- Tenofovir disoproxil fumarate and Historical Data
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Aug 2019to 13 Jul 2021
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged more than 20 years old;
- CHB patients who have been treated with Viread® for more than 1 year;
- Serum HBV DNA level is undetectable (not detected or <20 IU/mL) at screening;
- Informed consent must be obtained before the commencement of any screening procedures or study drugs
Who cannot join
- Patients with active HCC or other types of malignancy;
- Patients with impaired renal function (defined as eGFR ≦ 30 mL/min/1.73m2);
- Patients with hepatitis A (HAV), hepatitis C (HCV), hepatitis D (HDV) or human immunodeficiency virus (HIV) coinfection;
- Patients with alcohol dependence or addiction;
- Patients with autoimmune hepatitis;
- Patients with primary biliary cholangitis (PBC);
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- Pregnancy, planning on getting pregnant, or breast-feeding;
- History of allergy, hypersensitivity, intolerance, or experiencing severe adverse reactions to tenofovir or any ingredient of the study drug;
- Not suitable for participating in this trial at the investigator's discretion.
- Historical Control Group
- Eligible individuals will be obtained from the TCVGH historical database based on matching (1:1) in terms of age (±5 years) and gender. To be eligible for the study, subjects must meet all of the following criteria:
- Male or female aged more than 20 years old;
- CHB patients who had been treated with Viread® for more than 1 year;
- Patients who had discontinued Viread® therapy for at least 24 weeks during the period from January 2014 to December 2021 and had undetectable HBV DNA (not detected or <20 IU/mL) in serum at the time of discontinuation;
- Patients who have the data of HBV DNA level 24 weeks after the time of discontinuation, with a time window of +4 weeks is allowed;
- The informed consent requirement will be waived based on the approval of IRB.
Trial locations and contacts
1 site in 1 country.
About this study
This is a phase IV, open label, historical controlled comparative study to evaluate the efficacy and safety of Ricovir® in maintaining durability of viral response in CHB patients who have been treated with Viread® and have undetectable HBV DNA in serum by real-time polymerase chain reaction (PCR) assay.
- Conditions
- Chronic Hepatitis B Infection
- Being tested
- Tenofovir disoproxil fumarate, Historical Data
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir disoproxil fumarateDrug
Ricovir® (tenofovir disoproxil fumarate 300 mg) 1 tablet daily. The overall treatment period is 24 weeks.
Historical DataOther
Historical Data
| Study group | Role | What they receive |
|---|---|---|
| Ricovir® group | Experimental | Not described Receives: Drug: Tenofovir disoproxil fumarate |
| Historical Control Group | Other | Not described Receives: Other: Historical Data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the rates of virological recurrence of HBV
To assess the rates of virological recurrence of HBV at Week 24 with Ricovir® treatment.
Measured: Week 24
Secondary outcomes (3)
Comparison of the HBV DNA levels between Ricovir® group and historical control group
To compare the HBV DNA levels at Week 24 between Ricovir® group and historical control group.
Measured: Week 24
Comparison of the rates of virological recurrence of HBV between Ricovir® group and historical control group.
To compare the rates of virological recurrence of HBV at Week 24 between Ricovir® group and historical control group.
Measured: Week 24
Monitoring of Safety profile for subjects in Ricovir® group
For subjects in Ricovir® group, physical examination, vital signs, HBV DNA level, and concomitant medications will be evaluated at Week 4, 12 and 24 after treatment. Hematology and clinical biochemistry will be performed every 12 weeks. Adverse events (AEs) will be monitored continuously during the study.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start21 Aug 2019
- Primary completion13 Jul 2021
- Study completion13 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis B InfectionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylan (Taiwan) Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sanjay Hadigal, Dr., Study director, Mylan Pharmaceuticals Private Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355467
- Sponsor's protocol ID
- Mylan-Ricovir-TW-01
- Status last verified
- Apr 2022
- First submitted
- 25 Apr 2022
- Last updated
- 2 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ricovir® in Maintaining Durability of Viral Response in Chronic Hepatitis B Patients Who Have Been Treated With Viread® and Have Undetectable HBV DNA in Serum
- ClinicalTrials.gov ID
- NCT05355467
- Acronym / sponsor ID
- Mylan-Ricovir-TW-01
- Conditions
- Chronic Hepatitis B Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mylan (Taiwan) LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2019 (actual)
- Primary completion
- 13 Jul 2021 (actual)
- Study completion
- 13 Jul 2021 (actual)
- First posted
- 2 May 2022 (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.
This is a phase IV, open label, historical controlled comparative study to evaluate the efficacy and safety of Ricovir® in maintaining durability of viral response in CHB patients who have been treated with Viread® and have undetectable HBV DNA in serum by real-time polymerase chain reaction (PCR) assay.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ricovir® group | Experimental | Drug: Tenofovir disoproxil fumarate |
| Historical Control Group | Other | Other: Historical Data |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female aged more than 20 years old;
- CHB patients who have been treated with Viread® for more than 1 year;
- Serum HBV DNA level is undetectable (not detected or <20 IU/mL) at screening;
- Informed consent must be obtained before the commencement of any screening procedures or study drugs
Key exclusion criteria (16 listed)
- Patients with active HCC or other types of malignancy;
- Patients with impaired renal function (defined as eGFR ≦ 30 mL/min/1.73m2);
- Patients with hepatitis A (HAV), hepatitis C (HCV), hepatitis D (HDV) or human immunodeficiency virus (HIV) coinfection;
- Patients with alcohol dependence or addiction;
- Patients with autoimmune hepatitis;
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 |
|---|---|---|
| Tenofovir disoproxil fumarateRicovir® (tenofovir disoproxil fumarate 300 mg) 1 tablet daily. The overall treatment period is 24 weeks. | Drug | Ricovir® group |
| Historical DataHistorical Data | Other | Historical Control Group |
Primary outcome
Assessment of the rates of virological recurrence of HBV
Time frame: Week 24
To assess the rates of virological recurrence of HBV at Week 24 with Ricovir® treatment.
3 secondary outcomes
Comparison of the HBV DNA levels between Ricovir® group and historical control group
Time frame: Week 24
Comparison of the rates of virological recurrence of HBV between Ricovir® group and historical control group.
Time frame: Week 24
Monitoring of Safety profile for subjects in Ricovir® group
Time frame: Up to 24 weeks
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 2 May 2022.
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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.
Sanjay Hadigal, Dr. study director
Mylan Pharmaceuticals Private Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tenofovir disoproxil fumarate and Historical Data in people with Chronic Hepatitis B Infection, run by Mylan (Taiwan) Ltd at 1 site in Taiwan.
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 16 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 2 May 2022. 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 Taiwan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Assessment of the rates of virological recurrence of HBV (time frame: Week 24). 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 2 May 2022.