Hepatitis B, ChronicPhase 1/2NCT02338674
TDF and LdT in Immune-tolerant CHB Patients Awaiting Assisted Reproduction
A Phase 1/2 study testing Tenofovir and telbivudine and Tenofovir in people with Hepatitis B, Chronic, run by Fuzhou General Hospital at 1 site in China.
Trial summary
Immune-tolerant patients with chronic hepatitis B (CHB) awaiting assisted reproduction (AR) are required to initiate antiviral therapy due to laboratory safety. Additionally, rapid virus elimination is suggested to faciliate timely performance of AR. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- Tenofovir and telbivudine and Tenofovir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Oct 2017
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- aged 18-45 years old with artificial reproductive needs
- Liver function (ALT) <40U/L for male and <30 for female
- HBV-DNA> 10e+5
- HBVeAg +
- History> 0.5 years
Who cannot join
- Cirrhosis
- Combined with other liver diseases such as autoimmune liver disease, alcoholic liver disease, fatty liver
- Liver or other parts of malignancies
- Bilirubin> 17.1
- GGT> 2ULN
- Liver transplant patients
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- combined HCV, HDV, HIV infection
- A history of anti-HBV drug resistance
- History of habitual abortion
- previous fetal malformation history
- CRP> 3.0ng / ml
- Uncontrolled hypertension
- Proteinuria or Calculated creatinine clearance < 70 mL/min
- Heart failure or acute coronary syndrome
- Coagulopathy
- Drug or alcohol addiction
- Hyperlipidemia LDL> 4.6 or TG> 2.0
- Alphafetoprotein > 50 ng/mL
- Received interferon (pegylated or not) therapy within 6 months of the screening visit
- Evidence of hepatocellular carcinoma
- Received solid organ or bone marrow transplantation
- Was currently receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents
- Known hypersensitivity to the study drugs, the metabolites, or formulation excipients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combination Therapy of Tenofovir and Telbivudine in Immune-tolerant Patients With Chronic Hepatitis B Awaiting Assisted Reproduction
Immune-tolerant patients with chronic hepatitis B (CHB) awaiting assisted reproduction (AR) are required to initiate antiviral therapy due to laboratory safety. Additionally, rapid virus elimination is suggested to faciliate timely performance of AR. However, no consensus is reached regarding the antiviral therapy in this group. This study aimed to explore the efficacy and safety of tenofovir (TDF) and telbivudine (LdT) in this population.
- Conditions
- Hepatitis B, Chronic
- Being tested
- Tenofovir and telbivudine, Tenofovir
- 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 and telbivudineDrug
Also called combination therapy
tenofovir and telbivudine administered at least 48 weeks
TenofovirDrug
Also called single therapy
tenofovir administered at least 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| COM | Experimental | COM group receives combination therapy of tenofovir and telbivudine (TDF and LdT) for at least 48 weeks Receives: Drug: Tenofovir and telbivudine |
| TDF | Active comparator | TDF group receives single therapy of tenofovir (TDF) for at least 48 weeks Receives: Drug: Tenofovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With HBV DNA < 500 Copies/mL at Week 12
Measured: week 12
Secondary outcomes (10)
Percentage of Participants With HBV DNA < 500 Copies/mL at Week 24, 36 and 48
Measured: Week 24, 36 and 48
Number of Participants With Normal Alanine Aminotransferase (ALT) at Week 12, 24, 36 and 48
Measured: Week 12, 24, 36 and 48
Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 12, 24, 36 and 48
Measured: Week 12, 24, 36 and 48
Number of Participants With Seroconversion to Antibody Against HBeAg (AntiHBe) at Week 12, 24, 36 and 48
Measured: Week 12, 24, 36 and 48
Number of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12, 24, 36 and 48
Measured: Week 12, 24, 36 and 48
Number of Participants With Seroconversion to Antibody to HBsAg (AntiHBs) at Week 12, 24, 36 and 48
Measured: Week 12, 24, 36 and 48
Occurrence of HBV Resistance Mutations
Measured: Baseline to Week 48
off-treatment recurrence of HBV
Measured: Week 72 to 96
Down syndrome Occurrence
Measured: week 13 of pregnancy
Fetal Malformations Occurrence
Measured: week 26 of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startOct 2014
- Primary completionOct 2016
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fuzhou General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongliang Li, Fuzhou General Hospital
- Investigators
- Dongliangli Li, Dr., Study chair, Department of Hepatobiliary Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338674
- Sponsor's protocol ID
- HBV-AR
- Status last verified
- Sep 2018
- First submitted
- 11 Jan 2015
- Last updated
- 24 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Therapy of Tenofovir and Telbivudine in Immune-tolerant Patients With Chronic Hepatitis B Awaiting Assisted Reproduction
- ClinicalTrials.gov ID
- NCT02338674
- Acronym / sponsor ID
- HBV-AR
- Conditions
- Hepatitis B, Chronic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Fuzhou General HospitalUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 14 Jan 2015 (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.
Immune-tolerant patients with chronic hepatitis B (CHB) awaiting assisted reproduction (AR) are required to initiate antiviral therapy due to laboratory safety. Additionally, rapid virus elimination is suggested to faciliate timely performance of AR. However, no consensus is reached regarding the antiviral therapy in this group. This study aimed to explore the efficacy and safety of tenofovir (TDF) and telbivudine (LdT) in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COM | Experimental | Drug: Tenofovir and telbivudineCOM group receives combination therapy of tenofovir and telbivudine (TDF and LdT) for at least 48 weeks |
| TDF | Active comparator | Drug: TenofovirTDF group receives single therapy of tenofovir (TDF) for at least 48 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- aged 18-45 years old with artificial reproductive needs
- Liver function (ALT) <40U/L for male and <30 for female
- HBV-DNA> 10e+5
- HBVeAg +
- History> 0.5 years
Key exclusion criteria (23 listed)
- Cirrhosis
- Combined with other liver diseases such as autoimmune liver disease, alcoholic liver disease, fatty liver
- Liver or other parts of malignancies
- Bilirubin> 17.1
- GGT> 2ULN
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 and telbivudineAlso: combination therapytenofovir and telbivudine administered at least 48 weeks | Drug | COM |
| TenofovirAlso: single therapytenofovir administered at least 48 weeks | Drug | TDF |
Primary outcome
Percentage of Participants With HBV DNA < 500 Copies/mL at Week 12
Time frame: week 12
10 secondary outcomes
Percentage of Participants With HBV DNA < 500 Copies/mL at Week 24, 36 and 48
Time frame: Week 24, 36 and 48
Number of Participants With Normal Alanine Aminotransferase (ALT) at Week 12, 24, 36 and 48
Time frame: Week 12, 24, 36 and 48
Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 12, 24, 36 and 48
Time frame: Week 12, 24, 36 and 48
Number of Participants With Seroconversion to Antibody Against HBeAg (AntiHBe) at Week 12, 24, 36 and 48
Time frame: Week 12, 24, 36 and 48
Number of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12, 24, 36 and 48
Time frame: Week 12, 24, 36 and 48
Number of Participants With Seroconversion to Antibody to HBsAg (AntiHBs) at Week 12, 24, 36 and 48
Time frame: Week 12, 24, 36 and 48
Occurrence of HBV Resistance Mutations
Time frame: Baseline to Week 48
off-treatment recurrence of HBV
Time frame: Week 72 to 96
Down syndrome Occurrence
Time frame: week 13 of pregnancy
Fetal Malformations Occurrence
Time frame: week 26 of pregnancy
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 24 Sep 2018.
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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.
Dongliangli Li, Dr. study chair
Department of Hepatobiliary Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tenofovir and telbivudine and Tenofovir in people with Hepatitis B, Chronic, run by Fuzhou General Hospital at 1 site in China.
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 5 inclusion and 23 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 24 Sep 2018. 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 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 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?
Percentage of Participants With HBV DNA < 500 Copies/mL at Week 12 (time frame: week 12). 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 24 Sep 2018.