Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 11 for:    "Thrombocytopenic Purpura, Autoimmune" | "Methylprednisolone"
Previous Study | Return to List | Next Study

Treatment of ITP With Rituximab and / or Accutane

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02757196
Recruitment Status : Unknown
Verified May 2016 by Peking University People's Hospital.
Recruitment status was:  Not yet recruiting
First Posted : May 2, 2016
Last Update Posted : May 13, 2016
Sponsor:
Collaborator:
Beijing Hospital
Information provided by (Responsible Party):
Peking University People's Hospital

Brief Summary:
a prospective, multicenter, randomized, open-label, Phase II, two arms interventional trial performed in 5 departments of hematology in China

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia Drug: Rituximab plus methylprednisolone Drug: methylprednisolone Phase 2

Detailed Description:
This is a prospective, multicenter, randomized, open-label, Phase II, two arms interventional trial performed in 5 departments of hematology in China. The investigators explore the efficacy and safety of Rituximab plus short-term methylprednisolone compare standard dose methylprednisolone in newly diagnosed ITP participants.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rituximab Plus Short-term Methylprednisolone Versus Standard Dose Methylprednisolone in Newly Diagnosed Participants With Immune Thrombocytopenia (ITP): A Multicenter, Randomized Phase II Study in China
Study Start Date : May 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: Rituximab plus methylprednisolone
Combination therapy with rituximab (1000mg IV day1, week 3, week 17 , and week 19)plus short-term methylprednisolone (1mg/kg, oral or IV; reduce to 50% of base dose at week 4, then reduce 8mg every 1 week until stopped).
Drug: Rituximab plus methylprednisolone
rituximab (1000mg IV day1, week 3, week 17 , and week 19)
Other Name: monoclone antibody of cluster of differentiation antigen 20

Active Comparator: Methylprednisolone
standard dose methylprednisolone alone (1mg/kg, oral or IV; begin to reduce at week 4, reduce 8mg every 2 weeks, then another 8 weeks later reduce 2-4mg every 2-4 weeks).
Drug: methylprednisolone
1mg/kg, oral or IV; begin to reduce at week 4, reduce 8mg every 2 weeks, then another 8 weeks later reduce 2-4mg every 2-4 weeks
Other Name: intravenous methylprednisolone




Primary Outcome Measures :
  1. Relapse free survival [ Time Frame: From date of randomization until the date of relapse or death from any cause, whichever came first, assessed up to 1 year ]
    Relapse was defined as a drop in platelet count to <30 ×109/L following an initial best response (partial or complete response).


Secondary Outcome Measures :
  1. Cumulative response rate [ Time Frame: 1 year ]
    platelet count ≥ 30 x 10^9/L and at least 2-fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart, and absence of bleeding.

  2. Cumulative complete response rate [ Time Frame: 1 year ]
    platelet count >100 x 10^9/L, confirmed on at least 2 separate occasions at least 7 days apart, and absence of bleeding

  3. Cumulative relapse rate [ Time Frame: 1 year ]
    Time to response (from randomization to the achievement of response)Duration of response (from the initial response to the first relapse)

  4. adverse event/serious adverse event and cumulative rate of bleeding events [ Time Frame: 1 year ]
    adverse event/serious adverse event associated with study drugs and bleeding events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 30×109/L on two occasions or Platelets above 30×109/L combined with bleeding manifestation
  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

Information from the National Library of Medicine

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): NCT02757196


Contacts
Layout table for location contacts
Contact: Xiao-Hui Zhang, Doctor 861088324577 zhangxh100@sina.com
Contact: Ru Feng, Doctor 861085136381 frbld@sina.com

Sponsors and Collaborators
Peking University People's Hospital
Beijing Hospital
Investigators
Layout table for investigator information
Study Chair: Xiao-jun Huang, Dr Peking University People's Hospital

Layout table for additonal information
Responsible Party: Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT02757196     History of Changes
Other Study ID Numbers: ITP Treatment--100
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Peking University People's Hospital:
Immune Thrombocytopenia
Rituximab
methylprednisolone
Additional relevant MeSH terms:
Layout table for MeSH terms
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
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
Signs and Symptoms
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Inflammatory Agents
Antiemetics