The Combination of High-dose Dexamethasone and Acetylcysteine as the Treatment of Newly-diagnosed ITP
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ClinicalTrials.gov Identifier: NCT04368598 |
Recruitment Status : Unknown
Verified April 2020 by Xiao Hui Zhang, Peking University People's Hospital.
Recruitment status was: Recruiting
First Posted : April 30, 2020
Last Update Posted : April 30, 2020
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Condition or disease | Intervention/treatment | Phase |
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Immune Thrombocytopenia | Drug: Dexamethasone Drug: Acetylcysteine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 44 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Combination of High-dose Dexamethasone and Acetylcysteine as the Treatment of Newly-diagnosed Immune Thrombocytopenia: A Single-arm, Open-label Trial |
Actual Study Start Date : | April 1, 2019 |
Estimated Primary Completion Date : | December 31, 2020 |
Estimated Study Completion Date : | December 31, 2020 |

Arm | Intervention/treatment |
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Experimental: High-dose Dexamethasone plus Acetylcysteine
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.
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Drug: 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)
Other Names:
Drug: Acetylcysteine Acetylcysteine, po, 400mg tid, for 4 weeks
Other Name: YiWeiShi |
- Number of patients with durable response after 6 months [ Time Frame: 6 months ]Number of patients with durable response after 6 months
- Early response [ Time Frame: 7 days ]Number of patients with early response on day 7
- Initial response [ Time Frame: 1 month ]Number of patients with initial response at 1 month
- Bleeding [ Time Frame: 1 year ]Number of patients with bleeding complication therapy; bleeding score
- DOR [ Time Frame: 1 year ]duration of response
- Relapse [ Time Frame: 1 year ]Number of patients relapse during the observation
- Adverse events [ Time Frame: 1 year ]Number of patients with adverse events

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368598
Contact: Xiaohui Zhang, MD | +8613522338836 | zhangxh100@sina.com | |
Contact: Xinglin Wang, MD | +8613051522865 | wxlbjmu@163.com |
China, Beijing | |
Peking University Insititute of Hematology, Peking University People's Hospital | Recruiting |
Beijing, Beijing, China, 100044 | |
Contact: Xiaohui Zhang, MD +8613522338836 zhangxh100@sina.com |
Principal Investigator: | Xiaohui Zhang, MD | Peking University People's Hospital, Peking University Insititute of Hematology |
Responsible Party: | Xiao Hui Zhang, Vice president of Peking University Institute of Hematology, Peking University People's Hospital |
ClinicalTrials.gov Identifier: | NCT04368598 |
Other Study ID Numbers: |
ITP-PKU008 |
First Posted: | April 30, 2020 Key Record Dates |
Last Update Posted: | April 30, 2020 |
Last Verified: | April 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
immune thrombocytopenia acetylcysteine |
Thrombocytopenia Purpura, Thrombocytopenic, Idiopathic Blood Platelet Disorders Hematologic Diseases Purpura, Thrombocytopenic Purpura Blood Coagulation Disorders Thrombotic Microangiopathies Hemorrhagic Disorders Autoimmune Diseases Immune System Diseases Hemorrhage Pathologic Processes Skin Manifestations Acetylcysteine |
Dexamethasone Dexamethasone acetate BB 1101 N-monoacetylcystine Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |