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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

Tracking Information
First Submitted Date  ICMJE April 26, 2020
First Posted Date  ICMJE April 30, 2020
Last Update Posted Date April 30, 2020
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2020)
Number of patients with durable response after 6 months [ Time Frame: 6 months ]
Number of patients with durable response after 6 months
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2020)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Combination of High-dose Dexamethasone and Acetylcysteine as the Treatment of Newly-diagnosed ITP
Official Title  ICMJE The Combination of High-dose Dexamethasone and Acetylcysteine as the Treatment of Newly-diagnosed Immune Thrombocytopenia: A Single-arm, Open-label Trial
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Immune Thrombocytopenia
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Drug: Dexamethasone
  • Drug: Acetylcysteine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 28, 2020)
44
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xiaohui Zhang, MD +8613522338836 zhangxh100@sina.com
Contact: Xinglin Wang, MD +8613051522865 wxlbjmu@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04368598
Other Study ID Numbers  ICMJE ITP-PKU008
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Xiao Hui Zhang, Peking University People's Hospital
Study Sponsor  ICMJE Peking University People's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xiaohui Zhang, MD Peking University People's Hospital, Peking University Insititute of Hematology
PRS Account Peking University People's Hospital
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP