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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 : Recruiting
First Posted : April 30, 2020
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Xiao Hui Zhang, Peking University People's Hospital

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia Drug: Dexamethasone Drug: Acetylcysteine Phase 2

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
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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

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Arms and Interventions
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Arm Intervention/treatment
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.
 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:
  • HD-DXM
  • High-dose Dexamethasone

Drug: Acetylcysteine
Acetylcysteine, po, 400mg tid, for 4 weeks
Other Name: YiWeiShi


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with durable response after 6 months [ Time Frame: 6 months ]
    Number of patients with durable response after 6 months


Secondary Outcome Measures :
  1. Early response [ Time Frame: 7 days ]
    Number of patients with early response on day 7

  2. Initial response [ Time Frame: 1 month ]
    Number of patients with initial response at 1 month

  3. Bleeding [ Time Frame: 1 year ]
    Number of patients with bleeding complication therapy; bleeding score

  4. DOR [ Time Frame: 1 year ]
    duration of response

  5. Relapse [ Time Frame: 1 year ]
    Number of patients relapse during the observation

  6. Adverse events [ Time Frame: 1 year ]
    Number of patients with adverse events


Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  1. Clinically confirmed immune thrombocytopenic purpura (ITP) newly diagnosed
  2. 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)
  3. Subject is ≥ 18 years and ≤80years
  4. Subject has signed and dated written informed consent.
  5. Fertile patients must use effective contraception during treatment and observational period
  6. Negative pregnancy test

Exclusion Criteria:

  1. Have an impaired renal function as indicated by a serum creatinine level > 2.0 mg/dL
  2. 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
  3. Have a New York Heart Classification III or IV heart disease
  4. Have a history of severe psychiatric disorder or are unable to comply with study and follow-up procedures
  5. Have active hepatitis B or hepatitis C infection
  6. Have a HIV infection
  7. Have active infection requiring antibiotic therapy within 7 days prior to study entry
  8. Are pregnant or lactating women, or plan to become pregnant or impregnated within 12 months of receiving study drug
  9. Previous treatment with rituximab
  10. Previous splenectomy
  11. Had previous or concomitant malignant disease
  12. Not willing to participate in the study.
  13. Expected survival of < 2 years
  14. Intolerant to murine antibodies
  15. Immunosuppressive treatment within the last month
  16. Connective tissue disease
  17. Autoimmune hemolytic anemia
  18. Patients currently involved in another clinical trial with evaluation of drug treatment
Contacts and Locations
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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


Contacts
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Contact: Xiaohui Zhang, MD +8613522338836 zhangxh100@sina.com
Contact: Xinglin Wang, MD +8613051522865 wxlbjmu@163.com

Locations
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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   
Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Principal Investigator: Xiaohui Zhang, MD Peking University People's Hospital, Peking University Insititute of Hematology
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiao Hui Zhang, Peking University People's Hospital:
immune thrombocytopenia
acetylcysteine
Additional relevant MeSH terms:
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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