Immune ThrombocytopeniaPhase 2NCT05494307
The Combination of Terbutaline and Danazol as the Treatment of Corticosteroid-resistant/Relapse Immune Thrombocytopenia
A Phase 2 study testing Terbutaline and Danazol in people with Immune Thrombocytopenia, run by Peking University People's Hospital.
Trial summary
A randomized, open-label, multicenter study to compare the efficacy and safety of terbutaline plus danazol compared to danazol monotherapy for the second-line treatment of adults with corticosteroid-resistant or relapsed primary immune thrombocytopenia (ITP). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Immune Thrombocytopenia
- What is being tested?
- Terbutaline and Danazol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 28 Feb 2024
- Phase
- Phase 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Pregnant or lactating women;
- Secondary ITP (have a known diagnosis of connective tissue diseases, malignancy, active infection, HIV infections or hepatitis B virus or hepatitis C virus infections);
- Received drugs affecting the platelet counts within 6 months before the screening visit (e.g., chemotherapy, anticoagulants, etc);
- Severe medical condition (lung, heart, hepatic or renal disorder);
- Patients who are deemed unsuitable for the study by the investigator.
- Patients who had hypertension, diabetes mellitus, hyperthyroidism or coronary heart disease.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter Randomized Trial of Second Line Treatment for Corticosteroid-Resistant or Relapsed Immune Thrombocytopenia: Combined Terbutaline and Danazol Versus Danazol Monotherapy
A randomized, open-label, multicenter study to compare the efficacy and safety of terbutaline plus danazol compared to danazol monotherapy for the second-line treatment of adults with corticosteroid-resistant or relapsed primary immune thrombocytopenia (ITP).
Read the detailed description
The investigators are undertaking a parallel group, multicenter, randomized controlled trial of 228 adults with ITP in China. Patients were randomized to terbutaline plus danazol compared to danazol monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.
- Conditions
- Immune Thrombocytopenia
- Being tested
- Terbutaline, Danazol
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerbutalineDrug
Orally terbutaline at a dose of 2.5 mg three times daily for 16 weeks
DanazolDrug
Orally danazol at a dose of 200 mg twice daily for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Terbutaline plus danazol | Experimental | Terbutaline: A dose of 2.5 mg three times daily for 16 weeks Danazol: A dose of 200 mg twice daily for 16 weeks Receives: Drug: Terbutaline; Drug: Danazol |
| Danazol monotherapy | Active comparator | Danazol: A dose of 200 mg twice daily for 16 weeks Receives: Drug: Danazol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response
Achieving a platelet count ≥ 30 × 10^9/L confirmed on at least two separate occasions (at least 7 days apart), at least a doubling of the baseline platelet count without any other ITP-specific treatment and the absence of bleeding.
Measured: From date of randomization until 1 years or the end of follow-up
Secondary outcomes (11)
Sustained response
maintenance of a platelet count > 30 × 10^9/L, an absence of bleeding, and no requirement for any other ITP-specific treatment for 6 consecutive months after achievement of OR
Measured: From date of randomization until 1 years or the end of follow-up
Complete response
a platelet count ≥ 100 × 10^9/L measured on two occasions at least 7 days apart and the absence of bleeding
Measured: From date of randomization until 1 years or the end of follow-up
Remission
a durable platelet count > 30 × 109/L without bleeding up to 12 months after randomization
Measured: at 12-month follow-up
Time to response
the time from starting treatment to the time a response was achieved.
Measured: From date of randomization until 1 years or the end of follow-up
Duration of response
time from OR until loss of response or until the last follow-up visit
Measured: From date of randomization until 1 years or the end of follow-up
Rescue therapy
any new medical intervention taken to increase the platelet count or prevent bleeding events or an increase in the dose of concomitant treatments
Measured: From date of randomization until 1 years or the end of follow-up
Associated factors of treatment failure, OR, SR and remission
Factors that are associated with treatment failure, OR, SR and remission
Measured: From date of randomization until 1 years or the end of follow-up
Number of patients with bleeding
Number of patients with bleeding complication (WHO bleeding score)
Measured: From date of randomization until 1 years or the end of follow-up
Number of patients with side effects
Number of patients with Medication adverse events.
Measured: From date of randomization until 1 years or the end of follow-up
Relapse
Loss of OR
Measured: From date of randomization until 1 years or the end of follow-up
Relapse-free survival
the time interval between achievement of OR and relapse or the end of the follow-up
Measured: From date of randomization until 1 years or the end of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao Hui Zhang, Peking University People's Hospital
- Investigators
- Xiao-Hui Zhang, MD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494307
- Sponsor's protocol ID
- PKU-ITP039
- Status last verified
- Aug 2022
- First submitted
- 6 Aug 2022
- Last updated
- 9 Aug 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 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Trial of Second Line Treatment for Corticosteroid-Resistant or Relapsed Immune Thrombocytopenia: Combined Terbutaline and Danazol Versus Danazol Monotherapy
- ClinicalTrials.gov ID
- NCT05494307
- Acronym / sponsor ID
- PKU-ITP039
- Conditions
- Immune Thrombocytopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 9 Aug 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.
A randomized, open-label, multicenter study to compare the efficacy and safety of terbutaline plus danazol compared to danazol monotherapy for the second-line treatment of adults with corticosteroid-resistant or relapsed primary immune thrombocytopenia (ITP).
Detailed description
The investigators are undertaking a parallel group, multicenter, randomized controlled trial of 228 adults with ITP in China. Patients were randomized to terbutaline plus danazol compared to danazol monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Terbutaline plus danazol | Experimental | Drug: Terbutaline, Drug: DanazolTerbutaline: A dose of 2.5 mg three times daily for 16 weeks Danazol: A dose of 200 mg twice daily for 16 weeks |
| Danazol monotherapy | Active comparator | Drug: DanazolDanazol: A dose of 200 mg twice daily for 16 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Pregnant or lactating women;
- Secondary ITP (have a known diagnosis of connective tissue diseases, malignancy, active infection, HIV infections or hepatitis B virus or hepatitis C virus infections);
- Received drugs affecting the platelet counts within 6 months before the screening visit (e.g., chemotherapy, anticoagulants, etc);
- Severe medical condition (lung, heart, hepatic or renal disorder);
- Patients who are deemed unsuitable for the study by the investigator.
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 |
|---|---|---|
| TerbutalineOrally terbutaline at a dose of 2.5 mg three times daily for 16 weeks | Drug | Terbutaline plus danazol |
| DanazolOrally danazol at a dose of 200 mg twice daily for 16 weeks | Drug | Danazol monotherapy, Terbutaline plus danazol |
Primary outcome
Overall response
Time frame: From date of randomization until 1 years or the end of follow-up
Achieving a platelet count ≥ 30 × 10^9/L confirmed on at least two separate occasions (at least 7 days apart), at least a doubling of the baseline platelet count without any other ITP-specific treatment and the absence of bleeding.
11 secondary outcomes
Sustained response
Time frame: From date of randomization until 1 years or the end of follow-up
Complete response
Time frame: From date of randomization until 1 years or the end of follow-up
Remission
Time frame: at 12-month follow-up
Time to response
Time frame: From date of randomization until 1 years or the end of follow-up
Duration of response
Time frame: From date of randomization until 1 years or the end of follow-up
Rescue therapy
Time frame: From date of randomization until 1 years or the end of follow-up
Associated factors of treatment failure, OR, SR and remission
Time frame: From date of randomization until 1 years or the end of follow-up
Number of patients with bleeding
Time frame: From date of randomization until 1 years or the end of follow-up
Number of patients with side effects
Time frame: From date of randomization until 1 years or the end of follow-up
Relapse
Time frame: From date of randomization until 1 years or the end of follow-up
Relapse-free survival
Time frame: From date of randomization until 1 years or the end of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 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.
Xiao-Hui Zhang, MD principal investigator
Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Terbutaline and Danazol in people with Immune Thrombocytopenia, run by Peking University People's Hospital.
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 0 inclusion and 6 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 9 Aug 2022. 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.
What does this phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ye-Jun Wu, MD (13522338836, wyejun1999@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response (time frame: From date of randomization until 1 years or the end of follow-up). 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 9 Aug 2022.