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Trial record 3 of 36 for:    DANAZOL

The Combination of Atorvastatin, Acetylcysteine and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia

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ClinicalTrials.gov Identifier: NCT03460808
Recruitment Status : Not yet recruiting
First Posted : March 9, 2018
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
Xiao-hui Zhang, Peking University People's Hospital

Brief Summary:
Single-arm, open-lable, multicentre study to compare the efficacy and safety of atorvastatin, acetylcysteine plus danazol with danazol monotherapy in patients with corticosteroidresistant/relapsed ITP.

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia Drug: atorvastatin Drug: Acetylcysteine Drug: Danazol Phase 1 Phase 2

Detailed Description:

Immune thrombocytopenia (ITP) is a severe bleeding disorder. Approximately 2/3 of patients achieve remission from first-line therapies. However, the underlying mechanism of corticosteroid-resistant or relapsed ITP is not well understood; thus, treatment remains a great challenge. Atorvastatin was shown to enhance bone marrow endothelial cell function and N-acetylcysteine (NAC) was shown to inhibit PLT binding to endothelial cell.

A multicentre prospective study was performed in non-splenectomized ITP patients who were either resistant to a standard dose of corticosteroids or had relapsed. Patients were randomized to atorvastatin, acetylcysteine plus danazol with danazol monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study, in order to compare the efficacy and safety of atorvastatin, acetylcysteine plus danazol with danazol monotherapy in patients with corticosteroid-resistant/relapsed ITP.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Combination of Atorvastatin, Acetylcysteine and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia
Estimated Study Start Date : March 10, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2023


Arm Intervention/treatment
Experimental: atorvastatin, acetylcysteine & danazol
atorvastatin 20mg qd po plus acetylcysteine 400mg tid po plus danazol 200mg bid po for 12 weeks
Drug: atorvastatin
Atorvastatin was used in combination with acetylcysteine and danazol.

Drug: Acetylcysteine
Acetylcysteine was used in combination with atorvastatin and danazol.

Drug: Danazol
Danazol was used in combination with atorvastatin and acetylcysteine or as the monotherapy
Other Names:
  • Danocrine
  • Cleregil
  • Danol




Primary Outcome Measures :
  1. the sustained platelet response at the 6-month follow-up [ Time Frame: From the start of study treatment (Day 1) up to the end of Month 6 ]
    The number of participants (responders) with platelet count >=30x10^9/L and at least a 2-fold increase in the baseline count (PR) or a platelet count >=100x10^9/L (CR) and the absence of bleeding, without rescue medication at 6-month follow-up.


Secondary Outcome Measures :
  1. overall response [ Time Frame: From the start of study treatment (Day 1) up to the end of Month 6 ]
    The number of participants with platelet count >=30×10^9/L at least once and at least a doubling of the baseline platelet count without the administration of any other platelet increasing therapy.

  2. time to response [ Time Frame: From the start of study treatment (Day 1) up to the end of Year 2 ]
    Time to response was defined as the time from starting treatment to the time to achieve the response.

  3. duration of response [ Time Frame: From the start of study treatment (Day 1) up to the end of Year 2 ]
    Duration of response was measured from the achievement of response to the loss of response.

  4. incidence of treatment-emergent adverse events [ Time Frame: From the start of study treatment (Day 1) up to the end of Year 2 ]
    All patients were assessed for treatment-emergent adverse events every week during the first 8 weeks of treatment, and at 2-week intervals thereafter. Adverse events were scaled according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ITP confirmed by excluding other supervened causes of thrombocytopenia;
  • Platelet count of less than 30×10^9/L at enrollment;
  • Patients who did not achieve a sustained response to treatment with full dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation;
  • ECOG<2.
  • EPCs in bone marrow less than 0.02%

Exclusion Criteria:

  • Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus)
  • congestive heart failure
  • severe arrhythmia
  • nursing or pregnant women
  • aspartate aminotransferase and alanine transaminase levels ≥ 3× the upper limit of the normal threshold criteria
  • creatinine or serum bilirubin levels each 1.5 times or more than the normal range
  • active or previous malignancy
  • Unable to do blood routine test for the sake of time, distance, economic issues or other reasons.

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): NCT03460808


Contacts
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Contact: Xiao-hui Zhang, Professor +86 010-88324516 zhangxh100@sina.com

Locations
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China, Beijing
Peking University Insititute of Hematology, Peking University People's Hospital Not yet recruiting
Beijing, Beijing, China, 100044
Contact: Xiao-hui Zhang, Professor       zhangxh100@sina.com   
Sponsors and Collaborators
Peking University People's Hospital

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Responsible Party: Xiao-hui Zhang, Professor, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03460808     History of Changes
Other Study ID Numbers: Z171100001017084
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018

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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:
steroid-resistant
refractory
Atorvastatin
Acetylcysteine
Danazol
Additional relevant MeSH terms:
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Danazol
Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Pathologic Processes
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Skin Manifestations
Signs and Symptoms
Acetylcysteine
Atorvastatin
N-monoacetylcystine
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents