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Anti-D for Treating Thrombocytopenia in Adults Infected With Hepatitis C Virus With or Without HIV Co-Infection

This study has been terminated.
(failure to enroll additional subjects)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00239733
First Posted: October 17, 2005
Last Update Posted: May 16, 2017
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.
Information provided by (Responsible Party):
Kristen Marks, National Institute of Allergy and Infectious Diseases (NIAID)
Results First Submitted: January 5, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Thrombocytopenia
Hepatitis C
HIV Infections
Intervention: Drug: Anti-D

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Anti-D

Participants will be given anti-D in an outpatient setting. Participants will be observed for any adverse effects for 1 hour postinfusion. Some participants may require additional doses of anti-D later in the study, depending on individual response to the drug; participants may receive 1 to 6 doses of anti-D.

Anti-D: 30-minute infusion administered in an outpatient setting


Participant Flow:   Overall Study
    Anti-D
STARTED   6 
COMPLETED   6 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Anti-D

Participants will be given anti-D in an outpatient setting. Participants will be observed for any adverse effects for 1 hour postinfusion. Some participants may require additional doses of anti-D later in the study, depending on individual response to the drug; participants may receive 1 to 6 doses of anti-D.

Anti-D: 30-minute infusion administered in an outpatient setting


Baseline Measures
   Anti-D 
Overall Participants Analyzed 
[Units: Participants]
 6 
Age 
[Units: Years]
Median (Full Range)
 51 
 (32 to 66) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      1  16.7% 
Male      5  83.3% 
Region of Enrollment 
[Units: Participants]
 
United States   6 
Other baseline characteristics 
[Units: Participants]
Count of Participants
 
HIV coinfected   1 
Cirrhosis   5 
Decompensated Cirrhosis   3 


  Outcome Measures
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1.  Primary:   Frequency and Severity of Adverse Events   [ Time Frame: Throughout study, for up to 12 weeks ]

2.  Primary:   Absolute Change in Platelet Count From Baseline   [ Time Frame: Through Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Kristen Marks
Organization: Weill Cornell
phone: 212-746-4177
e-mail: markskr@med.cornell.edu


Publications:

Responsible Party: Kristen Marks, National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00239733     History of Changes
Other Study ID Numbers: K23AI065319-01 ( U.S. NIH Grant/Contract )
First Submitted: October 13, 2005
First Posted: October 17, 2005
Results First Submitted: January 5, 2017
Results First Posted: May 16, 2017
Last Update Posted: May 16, 2017