Trial Outcomes & Findings for Anti-D for Treating Thrombocytopenia in Adults Infected With Hepatitis C Virus With or Without HIV Co-Infection (NCT NCT00239733)

Last Updated: 2017-05-16

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

6 participants

Primary outcome timeframe

Throughout study, for up to 12 weeks

Results posted on

2017-05-16

Participant milestones
Measure	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
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Withdrawal data not reported

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

Baseline characteristics by cohort
Measure	Anti-D n=6 Participants 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
Age, Continuous	51 years n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	5 Participants n=99 Participants
Region of Enrollment United States	6 participants n=99 Participants
Other baseline characteristics HIV coinfected	1 Participants n=99 Participants
Other baseline characteristics Cirrhosis	5 Participants n=99 Participants
Other baseline characteristics Decompensated Cirrhosis	3 Participants n=99 Participants

Timeframe: Throughout study, for up to 12 weeks

Outcome measures
Measure	Anti-D n=6 Participants 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
Frequency and Severity of Adverse Events Any SAE	3 Participants
Frequency and Severity of Adverse Events Post infusion reactions	2 Participants
Frequency and Severity of Adverse Events Hepatic decompensation	1 Participants
Frequency and Severity of Adverse Events Any Hyperbilirubinemia	6 Participants
Frequency and Severity of Adverse Events Gr 3-4 Hyperbilrubinemia	1 Participants
Frequency and Severity of Adverse Events Anemia (all grade 1)	5 Participants
Frequency and Severity of Adverse Events Fatigue	4 Participants
Frequency and Severity of Adverse Events Fever	2 Participants
Frequency and Severity of Adverse Events Dyspnea on exertion	3 Participants
Frequency and Severity of Adverse Events Headache (all grade 1)	2 Participants
Frequency and Severity of Adverse Events Depression (mild)	1 Participants
Frequency and Severity of Adverse Events hypothyroidism	1 Participants
Frequency and Severity of Adverse Events Neutropenia (likely sec to IFN)	4 Participants
Frequency and Severity of Adverse Events Hospitalized	3 Participants
Frequency and Severity of Adverse Events Death	1 Participants

Timeframe: Through Week 12

Outcome measures
Measure	Anti-D n=6 Participants 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
Absolute Change in Platelet Count From Baseline Platelet response >50,000/ul week 2	2 Participants
Absolute Change in Platelet Count From Baseline Platelet response >50,000/ul week 4	2 Participants
Absolute Change in Platelet Count From Baseline Platelet response >50,000/ul week 8	3 Participants
Absolute Change in Platelet Count From Baseline Platelet response >50,000/lu week 12	0 Participants
Absolute Change in Platelet Count From Baseline Tp-related dose interruption peginterferon/ribavir	1 Participants
Absolute Change in Platelet Count From Baseline Platelet response >50,000/ul week 1	1 Participants
Absolute Change in Platelet Count From Baseline Anemia-related dose interruption peginterferon	2 Participants
Absolute Change in Platelet Count From Baseline Anemia-related dose interruption ribavirin	5 Participants

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events
Measure	Anti-D n=6 participants at risk 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
Hepatobiliary disorders Hepatic decompensation	16.7% 1/6 • Number of events 1
Gastrointestinal disorders Gastroenteritis	16.7% 1/6 • Number of events 1
Nervous system disorders Seixzure/meningitis	16.7% 1/6 • Number of events 1
Infections and infestations Death (sepsis_	16.7% 1/6 • Number of events 1

Other adverse events
Measure	Anti-D n=6 participants at risk 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
Vascular disorders Post infusion reactions	33.3% 2/6 • Number of events 2
Hepatobiliary disorders Hyperbilirubinemia Gr 3-4	16.7% 1/6 • Number of events 1
Blood and lymphatic system disorders Anemia Gr 1	83.3% 5/6 • Number of events 5
Cardiac disorders Dyspnea on exertion	50.0% 3/6 • Number of events 3
Nervous system disorders Headache	16.7% 1/6 • Number of events 1
Endocrine disorders Hypothyroidism	16.7% 1/6 • Number of events 1

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