Long-term Effects of Thymosin Alpha 1 TreatmentNCT04901104
Long-term Prognosis of Patients With Sepsis After Immunotherapy
An observational study of Long-term Effects of Thymosin Alpha 1 Treatment, run by Sun Yat-sen University.
Trial summary
Current clinical studies of thymosin α1 for sepsis have focused on short-term outcomes (28-day or 90-day mortality), and lack of clinical data on long-term outcomes (3 year mortality) of patients with sepsis after immunotherapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Long-term Effects of Thymosin Alpha 1 Treatment
- What is being tested?
- Thymosin Alpha1
- How many people
- 900 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2021to 31 Mar 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Sepsis patients who discharged from hospital after recovery in the TESTS study
Who may be able to join
- Sepsis patients in the TESTS study Patients who discharged from hospital after recovery
Who cannot join
- None
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Long-term Prognosis After Thymosin Alpha 1 Treatment in Patients With Sepsis: A Multicenter Cohort Study
Current clinical studies of thymosin α1 for sepsis have focused on short-term outcomes (28-day or 90-day mortality), and lack of clinical data on long-term outcomes (3 year mortality) of patients with sepsis after immunotherapy.
Based on the preliminary clinical study (NCT02867267), this study will conduct long-term follow-up for sepsis patients to provide data support for the long-term prognosis of immunotherapy.
- Being tested
- Thymosin Alpha1
- Keywords
- long-term, thymosin alpha 1, sepsis, immunotherapy
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thymosin Alpha1Drug
Drug interventions have been done in previous clinical studies
| Study group | Role | What they receive |
|---|---|---|
| thymosin α1 group | The patient was treated with thymosin α1 in sepsis Receives: Drug: Thymosin Alpha1 | |
| placebo group | The patient was treated without thymosin α1 in sepsis |
What is being measured
The primary outcome is the main question the study is designed to answer.
three years mortality
Mortality rate of patients treated with thymosin α1 or placebo within 3 years
Measured: 3 years
Secondary outcomes (4)
Recurrence rate of sepsis
Percentage of recurrent sepsis within 5 years of discharge sepsis patients
Measured: 5 years
one year mortality
Mortality rate of patients treated with thymosin α1 or placebo within 1 year
Measured: 1 year
Five years mortality
Mortality rate of patients treated with thymosin α1 or placebo within 5 years
Measured: 5 years
short form 36 questionnaire
Quality of life of sepsis patients after 1 year of thymosin α1 or placebo treatment
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 posted25 May 2021
- Study start1 Jul 2021 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long-term Effects of Thymosin Alpha 1 TreatmentStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Jianfeng, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901104
- Sponsor's protocol ID
- Long-term prognosis in sepsis
- Status last verified
- May 2021
- First submitted
- 24 May 2021
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Prognosis After Thymosin Alpha 1 Treatment in Patients With Sepsis: A Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT04901104
- Acronym / sponsor ID
- Long-term prognosis in sepsis
- Keywords
- long-term, thymosin alpha 1, sepsis, immunotherapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 25 May 2021 (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.
Current clinical studies of thymosin α1 for sepsis have focused on short-term outcomes (28-day or 90-day mortality), and lack of clinical data on long-term outcomes (3 year mortality) of patients with sepsis after immunotherapy.
Based on the preliminary clinical study (NCT02867267), this study will conduct long-term follow-up for sepsis patients to provide data support for the long-term prognosis of immunotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| thymosin α1 group | – | Drug: Thymosin Alpha1The patient was treated with thymosin α1 in sepsis |
| placebo group | – | –The patient was treated without thymosin α1 in sepsis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Sepsis patients who discharged from hospital after recovery in the TESTS study
Key inclusion criteria (1 listed)
- Sepsis patients in the TESTS study Patients who discharged from hospital after recovery
Key exclusion criteria (1 listed)
- None
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 Alpha1Drug interventions have been done in previous clinical studies | Drug | thymosin α1 group |
Primary outcome
three years mortality
Time frame: 3 years
Mortality rate of patients treated with thymosin α1 or placebo within 3 years
4 secondary outcomes
Recurrence rate of sepsis
Time frame: 5 years
one year mortality
Time frame: 1 year
Five years mortality
Time frame: 5 years
short form 36 questionnaire
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
- This study is a follow-up study of TESTS studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Long-term Effects of Thymosin Alpha 1 Treatment, run by Sun Yat-sen University.
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: opening soon, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianfeng Wu (020-87755766-8453, wujianf@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
three years mortality (time frame: 3 years). 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 25 May 2021.