Immune ThrombocytopeniaPhase 2NCT04368598
The Combination of High-dose Dexamethasone and Acetylcysteine as the Treatment of Newly-diagnosed ITP
A Phase 2 study testing Dexamethasone and Acetylcysteine in people with Immune Thrombocytopenia, run by Peking University People's Hospital at 1 site in China.
Trial summary
A single-arm, open-label study to evaluate the efficacy and safety of Acetylcysteine plus high-dose Dexamethasone in adults newly diagnosed with 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?
- Dexamethasone and Acetylcysteine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 31 Dec 2020
- 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
- Clinically confirmed immune thrombocytopenic purpura (ITP) newly diagnosed
- Platelet count less than 30×10^9/L on two occasions or Platelets above 30×10^9/L combined with bleeding manifestation (WHO bleeding scale 2 or above)
- Subject is ≥ 18 years and ≤80years
- Subject has signed and dated written informed consent.
- Fertile patients must use effective contraception during treatment and observational period
- Negative pregnancy test
Who cannot join
- Have an impaired renal function as indicated by a serum creatinine level > 2.0 mg/dL
- Have an inadequate liver function as indicated by a total bilirubin level > 2.0 mg/dL and/or an aspartate aminotransaminase or alanine aminotransferase level > 3×upper limit of normal
- Have a New York Heart Classification III or IV heart disease
- Have a history of severe psychiatric disorder or are unable to comply with study and follow-up procedures
- Have active hepatitis B or hepatitis C infection
- Have a HIV infection
Show all 18Show fewer
- Have active infection requiring antibiotic therapy within 7 days prior to study entry
- Are pregnant or lactating women, or plan to become pregnant or impregnated within 12 months of receiving study drug
- Previous treatment with rituximab
- Previous splenectomy
- Had previous or concomitant malignant disease
- Not willing to participate in the study.
- Expected survival of < 2 years
- Intolerant to murine antibodies
- Immunosuppressive treatment within the last month
- Connective tissue disease
- Autoimmune hemolytic anemia
- Patients currently involved in another clinical trial with evaluation of drug treatment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Xiaohui Zhang, MD, +8613522338836, zhangxh100@sina.com
About this study
Official title: The Combination of High-dose Dexamethasone and Acetylcysteine as the Treatment of Newly-diagnosed Immune Thrombocytopenia: A Single-arm, Open-label Trial
A single-arm, open-label study to evaluate the efficacy and safety of Acetylcysteine plus high-dose Dexamethasone in adults newly diagnosed with primary immune thrombocytopenia (ITP).
Read the detailed description
This is a prospective, open-label, Phase II, single-arm interventional trial performed in a single center in China. The investigators explore the efficacy and safety of Acetylcysteine plus high-dose Dexamethasone in adults newly diagnosed with primary immune thrombocytopenia.
- Conditions
- Immune Thrombocytopenia
- Being tested
- Dexamethasone, Acetylcysteine
- Keywords
- immune thrombocytopenia, acetylcysteine
- 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.
DexamethasoneDrug
Also called HD-DXM, High-dose Dexamethasone
Dexamethasone, iv, 40 mg/d, for 4 days (The 4-day course of dexamethasone was repeated on days 11 to 14 in the case of lack of response by day 10)
AcetylcysteineDrug
Also called YiWeiShi
Acetylcysteine, po, 400mg tid, for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| High-dose Dexamethasone plus Acetylcysteine | Experimental | For all patients in this arm, DXM was administered intravenously at 40 mg daily for 4 consecutive days and then stopped. If platelet count remained below 30×10^9/L or there were bleeding symptoms by day 10 to 14, an additional 4-day course of DXM (40 mg daily) was given. Besides, all patients received Acetylcysteine orally at 0.4g three times a day for 4 consecutive weeks in the first month. Receives: Drug: Dexamethasone; Drug: Acetylcysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with durable response after 6 months
Number of patients with durable response after 6 months
Measured: 6 months
Secondary outcomes (6)
Early response
Number of patients with early response on day 7
Measured: 7 days
Initial response
Number of patients with initial response at 1 month
Measured: 1 month
Bleeding
Number of patients with bleeding complication therapy; bleeding score
Measured: 1 year
DOR
duration of response
Measured: 1 year
Relapse
Number of patients relapse during the observation
Measured: 1 year
Adverse events
Number of patients with adverse events
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 posted30 Apr 2020
- Study start1 Apr 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 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
- Xiaohui Zhang, MD, Principal investigator, Peking University People's Hospital, Peking University Insititute of Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04368598
- Sponsor's protocol ID
- ITP-PKU008
- Status last verified
- Apr 2020
- First submitted
- 26 Apr 2020
- Last updated
- 30 Apr 2020
- 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 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combination of High-dose Dexamethasone and Acetylcysteine as the Treatment of Newly-diagnosed Immune Thrombocytopenia: A Single-arm, Open-label Trial
- ClinicalTrials.gov ID
- NCT04368598
- Acronym / sponsor ID
- ITP-PKU008
- Conditions
- Immune Thrombocytopenia
- Keywords
- immune thrombocytopenia, acetylcysteine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 30 Apr 2020 (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 single-arm, open-label study to evaluate the efficacy and safety of Acetylcysteine plus high-dose Dexamethasone in adults newly diagnosed with primary immune thrombocytopenia (ITP).
Detailed description
This is a prospective, open-label, Phase II, single-arm interventional trial performed in a single center in China. The investigators explore the efficacy and safety of Acetylcysteine plus high-dose Dexamethasone in adults newly diagnosed with primary immune thrombocytopenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-dose Dexamethasone plus Acetylcysteine | Experimental | Drug: Dexamethasone, Drug: AcetylcysteineFor all patients in this arm, DXM was administered intravenously at 40 mg daily for 4 consecutive days and then stopped. If platelet count remained below 30×10^9/L or there were bleeding symptoms by day 10 to 14, an additional 4-day course of DXM (40 mg daily) was given. Besides, all patients received Acetylcysteine orally at 0.4g three times a day for 4 consecutive weeks in the first month. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinically confirmed immune thrombocytopenic purpura (ITP) newly diagnosed
- Platelet count less than 30×10^9/L on two occasions or Platelets above 30×10^9/L combined with bleeding manifestation (WHO bleeding scale 2 or above)
- Subject is ≥ 18 years and ≤80years
- Subject has signed and dated written informed consent.
- Fertile patients must use effective contraception during treatment and observational period
Key exclusion criteria (18 listed)
- Have an impaired renal function as indicated by a serum creatinine level > 2.0 mg/dL
- Have an inadequate liver function as indicated by a total bilirubin level > 2.0 mg/dL and/or an aspartate aminotransaminase or alanine aminotransferase level > 3×upper limit of normal
- Have a New York Heart Classification III or IV heart disease
- Have a history of severe psychiatric disorder or are unable to comply with study and follow-up procedures
- Have active hepatitis B or hepatitis C infection
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 |
|---|---|---|
| DexamethasoneAlso: HD-DXM, High-dose DexamethasoneDexamethasone, iv, 40 mg/d, for 4 days (The 4-day course of dexamethasone was repeated on days 11 to 14 in the case of lack of response by day 10) | Drug | High-dose Dexamethasone plus Acetylcysteine |
| AcetylcysteineAlso: YiWeiShiAcetylcysteine, po, 400mg tid, for 4 weeks | Drug | High-dose Dexamethasone plus Acetylcysteine |
Primary outcome
Number of patients with durable response after 6 months
Time frame: 6 months
Number of patients with durable response after 6 months
6 secondary outcomes
Early response
Time frame: 7 days
Initial response
Time frame: 1 month
Bleeding
Time frame: 1 year
DOR
Time frame: 1 year
Relapse
Time frame: 1 year
Adverse events
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
- 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.
Xiaohui Zhang, MD principal investigator
Peking University People's Hospital, Peking University Insititute of Hematology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexamethasone and Acetylcysteine in people with Immune Thrombocytopenia, run by Peking University People's 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 6 inclusion and 18 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 30 Apr 2020. 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 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 Xiaohui Zhang, MD (+8613522338836, zhangxh100@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with durable response after 6 months (time frame: 6 months). 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 30 Apr 2020.