Hepatitis B, ChronicPhase 3PEG-Tα1NCT02366247
Phase Ⅲ Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg-positive Chronic Hepatitis B
A Phase 3 study testing PEG-Tα1 and Adefovir in people with Hepatitis B, Chronic, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 32 sites in China.
Trial summary
This trial is to assess the efficacy and safety of Polyethylene Glycol thymosin alpha1 (PEG-Tα1), a new long immunomodulator (Category 1.1 of Chemical Drugs) being developed from Hansoh Pharmaceutical of China, in combination with adefovir in HBeAg-positive patients with chronic hepatitis B. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- PEG-Tα1 and Adefovir
- 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
- 463 participants
- Where
- 32 sitesChina
- Study dates
- Aug 2013to Feb 2016
- Phase
- Phase 3
- 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
- Chronic hepatitis B for more than 6 months, and didn't accept immunomodulating or anti-viral treatment within 6 months before the trial.
- ALT level > 2 × Upper Limit Normal (ULN).
- Serum bilirubin < 2 × ULN.
- Positive HBeAg and negative HBeAb.
- HBV-DNA between 1.00E＋05 IU/ml and 9.99E＋09 IU/ml.
- Informed Consent Form (ICF) signed.
Who cannot join
- Hepatitis A,C,D,E or HIV infection.
- Autoimmune hepatitis.
- Hepatic cirrhosis.
- Serum creatinine >1.5 × ULN or Ccr <50 ml/min, Haemoglobin <110g/L (male) or <100g/L (female), Platelet<80 E＋09/L, Serum albumin ≤ 35g/L, or Serum albumin/globulin (A/G) ≤0.9, Neutrophile granulocyte <1.0 E＋09/L, Prothrombin time>ULN＋3 seconds, Cholinesterase<4000U/L.
- Hepatitic carcinoma or Alpha Fetal Protein (AFP) >100ng/ml .
- Patients with other severe diseases combined, which could affect the therapy.
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- Patients accepted other clinical trial within 6 months before the first administrated.
- Thymosin allergy.
- Pregnant or breast feeding.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
China32 sites
302 Military Hoapital of China
Beijing, Beijing Municipality
Beijing YouAn Hospital, Capital Medical University
Beijing, Beijing Municipality
The First Hospital of Jilin University
Changchun, Jilin
The Second Xiangya Hospital of Central South University
Changsha, Hunan
The Third Xiangya Hospital of Central South University
Changsha, Hunan
West China Hospital Sichuan University
Chengdu, Sichuan
Southwest Hospital
Chongqing, Chongqing Municipality
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Hainan General Hospital
Haikou, Hainan
XiXi Hospital of Hangzhou
Hangzhou, Zhejiang
The First Affiliated Hospital of South China University
Hengyang, Hunan
Jinan Infectious Disease Hospital
Jinan, Shandong
Qilu Hospital of Shandong University
Jinan, Shandong
The First Hospital of Lanzhou University
Lanzhou, Gansu
81 Military Hospital of China
Nanjing, Jiangsu
Jiangsu Province Hospital
Nanjing, Jiangsu
The Second Hospital of Nanjing
Nanjing, Jiangsu
The Six People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality
The Sixth People's Hospital of Shenyang
Shenyang, Liaoning
Shenzhen People's Hospital
Shenzhen, Guangdong
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang
Tianjin Second People's Hospital
Tianjin, Tianjin Municipality
People's Hospital of Wuhan University
Wuhan, Hubei
Zhongshan Hospital of Hubei Province
Wuhan, Hubei
Tangdu Hospital
Xi’an, Shanxi
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi
Xijing Hospital
Xi’an, Shanxi
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu
Yanbian University Hospital
Yanbian, Jilin
About this study
Official title: Combination Treatment of Polyethylene Glycol Thymosin alpha1 (PEG-Tα1) and Adefovir for Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B: A Multi-center Randomized, Double-blind, Parallel-controlled Phase Ⅲ Trial
This trial is to assess the efficacy and safety of Polyethylene Glycol thymosin alpha1 (PEG-Tα1), a new long immunomodulator (Category 1.1 of Chemical Drugs) being developed from Hansoh Pharmaceutical of China, in combination with adefovir in HBeAg-positive patients with chronic hepatitis B.
Read the detailed description
A total of 463 HBeAg-positive patients were recruited from 33 hospitals in China, and randomized to two groups. The combination group received PEG-Tα1 (3.2 mg/ml, once a week, taken subcutaneously) and adefovir (10 mg, once daily, taken orally) for 48 weeks. The control group received placebo and adefovir. The primary endpoint was the loss of HBeAg at 48 weeks. The secondary endpoints included 1) loss of hepatitis B virus (HBV) DNA, 2) HBeAg seroconversion and 3) alanine aminotransferase (ALT) normalization etc. at week 4, 12, 24, 36 and 48. The number of CD4＋and CD8＋T cells was also determined during 48 weeks.
- Conditions
- Hepatitis B, Chronic
- Being tested
- PEG-Tα1, Placebo to match PEG-Tα1, Adefovir
- Keywords
- Polyethylene Glycol Thymosin alpha1, Adefovir, Hepatitis B e Antigens positive
- 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.
PEG-Tα1Drug
Also called Polyethylene Glycol thymosin alpha1
3.2mg/ml, once a week, taken subcutaneously
Placebo to match PEG-Tα1Drug
1ml, once a week, taken subcutaneously
AdefovirDrug
10 mg, once daily, taken orally for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| PEG-Tα1 | Experimental | PEG-Tα1 (3.2 mg/ml, once a week, taken subcutaneously) and adefovir (10 mg, once daily, taken orally) for 48 weeks Receives: Drug: PEG-Tα1; Drug: Adefovir |
| Placebo to match PEG-Tα1 | Placebo comparator | PEG-Tα1 placebo (1ml, once a week, taken subcutaneously) and adefovir (10 mg, once daily, taken orally) for 48 weeks Receives: Drug: Placebo to match PEG-Tα1; Drug: Adefovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss of HBeAg
Measured: 48 weeks
Secondary outcomes (3)
Loss of HBV DNA
Measured: week 4, 12, 24, 36 and 48
HBeAg seroconversion
Measured: week 4, 12, 24, 36 and 48
Alanine aminotransferase normalization
Measured: week 4, 12, 24, 36 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startAug 2013
- Primary completionDec 2015 (estimated)
- Study completionFeb 2016 (estimated)
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.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 463 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nanjing Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366247
- Sponsor's protocol ID
- HS-20046-3
- Acronym
- PEG-Tα1
- Status last verified
- Jan 2015
- First submitted
- 12 Feb 2015
- Last updated
- 19 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Treatment of Polyethylene Glycol Thymosin alpha1 (PEG-Tα1) and Adefovir for Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B: A Multi-center Randomized, Double-blind, Parallel-controlled Phase Ⅲ Trial
- ClinicalTrials.gov ID
- NCT02366247
- Acronym / sponsor ID
- PEG-Tα1 / HS-20046-3
- Conditions
- Hepatitis B, Chronic
- Keywords
- Polyethylene Glycol Thymosin alpha1, Adefovir, Hepatitis B e Antigens positive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 463 participants (actual)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Nanjing Medical University
- Study start
- Aug 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 19 Feb 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.
This trial is to assess the efficacy and safety of Polyethylene Glycol thymosin alpha1 (PEG-Tα1), a new long immunomodulator (Category 1.1 of Chemical Drugs) being developed from Hansoh Pharmaceutical of China, in combination with adefovir in HBeAg-positive patients with chronic hepatitis B.
Detailed description
A total of 463 HBeAg-positive patients were recruited from 33 hospitals in China, and randomized to two groups. The combination group received PEG-Tα1 (3.2 mg/ml, once a week, taken subcutaneously) and adefovir (10 mg, once daily, taken orally) for 48 weeks. The control group received placebo and adefovir. The primary endpoint was the loss of HBeAg at 48 weeks. The secondary endpoints included 1) loss of hepatitis B virus (HBV) DNA, 2) HBeAg seroconversion and 3) alanine aminotransferase (ALT) normalization etc. at week 4, 12, 24, 36 and 48. The number of CD4＋and CD8＋T cells was also determined during 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG-Tα1 | Experimental | Drug: PEG-Tα1, Drug: AdefovirPEG-Tα1 (3.2 mg/ml, once a week, taken subcutaneously) and adefovir (10 mg, once daily, taken orally) for 48 weeks |
| Placebo to match PEG-Tα1 | Placebo comparator | Drug: Placebo to match PEG-Tα1, Drug: AdefovirPEG-Tα1 placebo (1ml, once a week, taken subcutaneously) and adefovir (10 mg, once daily, taken orally) 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 (6 listed)
- Chronic hepatitis B for more than 6 months, and didn't accept immunomodulating or anti-viral treatment within 6 months before the trial.
- ALT level > 2 × Upper Limit Normal (ULN).
- Serum bilirubin < 2 × ULN.
- Positive HBeAg and negative HBeAb.
- HBV-DNA between 1.00E＋05 IU/ml and 9.99E＋09 IU/ml.
Key exclusion criteria (9 listed)
- Hepatitis A,C,D,E or HIV infection.
- Autoimmune hepatitis.
- Hepatic cirrhosis.
- Serum creatinine >1.5 × ULN or Ccr <50 ml/min, Haemoglobin <110g/L (male) or <100g/L (female), Platelet<80 E＋09/L, Serum albumin ≤ 35g/L, or Serum albumin/globulin (A/G) ≤0.9, Neutrophile granulocyte <1.0 E＋09/L, Prothrombin time>ULN＋3 seconds, Cholinesterase<4000U/L.
- Hepatitic carcinoma or Alpha Fetal Protein (AFP) >100ng/ml .
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-Tα1Also: Polyethylene Glycol thymosin alpha13.2mg/ml, once a week, taken subcutaneously | Drug | PEG-Tα1 |
| Placebo to match PEG-Tα11ml, once a week, taken subcutaneously | Drug | Placebo to match PEG-Tα1 |
| Adefovir10 mg, once daily, taken orally for 48 weeks | Drug | PEG-Tα1, Placebo to match PEG-Tα1 |
Primary outcome
Loss of HBeAg
Time frame: 48 weeks
3 secondary outcomes
Loss of HBV DNA
Time frame: week 4, 12, 24, 36 and 48
HBeAg seroconversion
Time frame: week 4, 12, 24, 36 and 48
Alanine aminotransferase normalization
Time frame: week 4, 12, 24, 36 and 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2015.
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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.
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PEG-Tα1 and Adefovir in people with Hepatitis B, Chronic, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 32 sites 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 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: status not confirmed, as of the sponsor's last update on 19 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
Loss of HBeAg (time frame: 48 weeks). 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 19 Feb 2015.