Chronic Hepatitis bPhase 4NCT03448744
Efficacy and Safety of Combination Therapy of Thymalfasin and Entecavir in HBeAg-positive ETV-experienced Patients
A Phase 4 study testing Thymosin Alpha1 and Entecavir in people with Chronic Hepatitis b, run by Wen-hong Zhang at 1 site in China.
Trial summary
This is a multicenter, randomized, open-label control trial of two arms conducted at 10 centres in China.The aim was to investigate whether sequential combination therapy with Thymosin alpha 1 and entecavir is superior to continuous ETV monotherapy in HBeAg-positive chronic hepatitis B patients with previous long-term… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Chronic Hepatitis b
- What is being tested?
- Thymosin Alpha1 and Entecavir
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2017to 30 Dec 2018
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- HBsAg positive and anti-HBs negative for more than 6 months
- Being currently treated with ETV ≥1 years
- HBeAg positivity and HBV DNA <60IU/mL with HBsAg <1500IU/mL and HBeAg <200S/CO at screening
- ALT ≤5*ULN and total bilirubin ≤2*ULN
- Age ≥ 18 yrs but ≤ 55 yrs
- Written informed consent
Who cannot join
- Patients who have contraindications for Thymosin alpha 1 in accordance with the approved summary of product characteristics
- Patients with ALT > 5 x ULN or total bilirubin >2*ULN
- Patients with evidence of hepatocellular carcinoma at screening
- Patients with Child-Pugh score ≥7 or had a history of hepatic encephalopathy or esophageal pile or ascites
- Patients with serological evidence of co-infection with hepatitis A virus, hepatitis C, human immunodeficiency virus or hepatitis D virus
- Patients with a history of excessive drinking: male >40g/d,female >40g/d
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- Pregnant or breast-feeding women
- A history of liver transplantation or planned for liver transplantation
- Patients of autoimmune disease
- Patients with other diseases combined
- Patients with creatinine >1.5*ULN
- Investigator considered not proper for participating the trial
- Patients with other maliginant tumor
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200040
Wenhong Zhang, PhD,MD, +86 21 52889999 ext. 8123, zhangwenhong@fudan.edu.cn
About this study
Official title: A Multicenter, Randomized, Open-label Control Study to Evaluate Efficacy and Safety of Combination Therapy of Thymalfasin and Entecavir in HBeAg-positive ETV-experienced Patients
This is a multicenter, randomized, open-label control trial of two arms conducted at 10 centres in China.The aim was to investigate whether sequential combination therapy with Thymosin alpha 1 and entecavir is superior to continuous ETV monotherapy in HBeAg-positive chronic hepatitis B patients with previous long-term entecavir therapy (≥ 2 years), and to select the optimal patients who may benefit from sequential combination therapy.
Read the detailed description
To investigate whether sequential combination therapy with Thymosin alpha 1 and entecavir is superior to continuous ETV monotherapy in HBeAg-positive chronic hepatitis B patients with previous long-term entecavir therapy (≥ 1 years), and to select the optimal patients who may benefit from sequential combination therapy.
- Conditions
- Chronic Hepatitis b
- Being tested
- Thymosin Alpha1, Entecavir
- Keywords
- thymosin alpha, entecavir
- 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.
Thymosin Alpha1Drug
Thymosin Alpha1 (1.6 mg subcutaneously injection twice a week) plus ETV (0.5 mg orally, daily) for 24 weeks, and followed by continuous ETV for at least 48 weeks
EntecavirDrug
ETV (0.5 mg orally, daily) for 72 weeks
| Study group | Role | What they receive |
|---|---|---|
| combiantion therapy group | Experimental | thymosin alpha 1 (1.6 mg subcutaneously injection twice a week) plus ETV (0.5 mg orally, daily) for 24 weeks, and followed by continuous ETV for at least 48 weeks Receives: Drug: Thymosin Alpha1; Drug: Entecavir |
| entecavir group | Placebo comparator | ETV (0.5 mg orally, daily) at least for 72 weeks Receives: Drug: Entecavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBeAg seroconversion rate at week 72
HBeAg seroconversion rate at week 72
Measured: week 72
Secondary outcomes (10)
HBeAg seroconversion rate at week 48
HBeAg seroconversion rate at week 48
Measured: week 48
HBsAg loss at week 48
HBsAg loss at week 48
Measured: week 48
HBsAg loss at week 72
HBsAg loss at week 72
Measured: week 72
HBsAg seroconversion at week 72
HBsAg seroconversion at week 72
Measured: week 72
HBsAg seroconversion at week 48
HBsAg seroconversion at week 48
Measured: week 48
HBsAg decline during the clinical trial
HBsAg decline during the clinical trial
Measured: week 12, weeek 24, week 36, week 48 and week 72
ALT normalization rate at week 72
ALT normalization rate at week 72
Measured: week 72
ALT normalization rate at week 48
ALT normalization rate at week 48
Measured: week 48
Rate of HBV DNA <20IU/mL at week 72
Rate of HBV DNA <20IU/mL at week 72
Measured: week 72
Rate of HBV DNA <20IU/mL at week 48
Rate of HBV DNA <20IU/mL at week 48
Measured: week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start25 Oct 2017
- Primary completion30 Dec 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis bStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wen-hong Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wen-hong Zhang, Huashan Hospital
- Investigators
- Wenhong Zhang, Ph.D, Principal investigator, Department of Infectious Diseases, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448744
- Sponsor's protocol ID
- KY2016-219
- Status last verified
- Feb 2018
- First submitted
- 22 Feb 2018
- Last updated
- 28 Feb 2018
- Results posted
- 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 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-label Control Study to Evaluate Efficacy and Safety of Combination Therapy of Thymalfasin and Entecavir in HBeAg-positive ETV-experienced Patients
- ClinicalTrials.gov ID
- NCT03448744
- Acronym / sponsor ID
- KY2016-219
- Conditions
- Chronic Hepatitis b
- Keywords
- thymosin alpha, entecavir
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Wen-hong ZhangUniversity, hospital or other
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 28 Feb 2018 (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 multicenter, randomized, open-label control trial of two arms conducted at 10 centres in China.The aim was to investigate whether sequential combination therapy with Thymosin alpha 1 and entecavir is superior to continuous ETV monotherapy in HBeAg-positive chronic hepatitis B patients with previous long-term entecavir therapy (≥ 2 years), and to select the optimal patients who may benefit from sequential combination therapy.
Detailed description
To investigate whether sequential combination therapy with Thymosin alpha 1 and entecavir is superior to continuous ETV monotherapy in HBeAg-positive chronic hepatitis B patients with previous long-term entecavir therapy (≥ 1 years), and to select the optimal patients who may benefit from sequential combination therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combiantion therapy group | Experimental | Drug: Thymosin Alpha1, Drug: Entecavirthymosin alpha 1 (1.6 mg subcutaneously injection twice a week) plus ETV (0.5 mg orally, daily) for 24 weeks, and followed by continuous ETV for at least 48 weeks |
| entecavir group | Placebo comparator | Drug: EntecavirETV (0.5 mg orally, daily) at least for 72 weeks |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- HBsAg positive and anti-HBs negative for more than 6 months
- Being currently treated with ETV ≥1 years
- HBeAg positivity and HBV DNA <60IU/mL with HBsAg <1500IU/mL and HBeAg <200S/CO at screening
- ALT ≤5*ULN and total bilirubin ≤2*ULN
- Age ≥ 18 yrs but ≤ 55 yrs
Key exclusion criteria (13 listed)
- Patients who have contraindications for Thymosin alpha 1 in accordance with the approved summary of product characteristics
- Patients with ALT > 5 x ULN or total bilirubin >2*ULN
- Patients with evidence of hepatocellular carcinoma at screening
- Patients with Child-Pugh score ≥7 or had a history of hepatic encephalopathy or esophageal pile or ascites
- Patients with serological evidence of co-infection with hepatitis A virus, hepatitis C, human immunodeficiency virus or hepatitis D virus
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 |
|---|---|---|
| Thymosin Alpha1Thymosin Alpha1 (1.6 mg subcutaneously injection twice a week) plus ETV (0.5 mg orally, daily) for 24 weeks, and followed by continuous ETV for at least 48 weeks | Drug | combiantion therapy group |
| EntecavirETV (0.5 mg orally, daily) for 72 weeks | Drug | combiantion therapy group, entecavir group |
Primary outcome
HBeAg seroconversion rate at week 72
Time frame: week 72
HBeAg seroconversion rate at week 72
10 secondary outcomes
HBeAg seroconversion rate at week 48
Time frame: week 48
HBsAg loss at week 48
Time frame: week 48
HBsAg loss at week 72
Time frame: week 72
HBsAg seroconversion at week 72
Time frame: week 72
HBsAg seroconversion at week 48
Time frame: week 48
HBsAg decline during the clinical trial
Time frame: week 12, weeek 24, week 36, week 48 and week 72
ALT normalization rate at week 72
Time frame: week 72
ALT normalization rate at week 48
Time frame: week 48
Rate of HBV DNA <20IU/mL at week 72
Time frame: week 72
Rate of HBV DNA <20IU/mL at week 48
Time frame: week 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- 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.
Wenhong Zhang, Ph.D principal investigator
Department of Infectious Diseases, Huashan Hospital
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 Thymosin Alpha1 and Entecavir in people with Chronic Hepatitis b, run by Wen-hong Zhang 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 6 inclusion and 13 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 28 Feb 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yiqi Yu, MD (+86-21-52888123, yyq19890619@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBeAg seroconversion rate at week 72 (time frame: week 72). 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 28 Feb 2018.