Trial Outcomes & Findings for Randomized Trial of IVIg With or Without Cyclophosphamide in Pemphigus (NCT NCT00483119)
NCT ID: NCT00483119
Last Updated: 2016-02-18
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
6 - 10 weeks after initiation of therapy
Results posted on
2016-02-18
Participant Flow
Participant milestones
| Measure |
IVIg Alone
IVIg alone
intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles
|
IVIg With Cyclophosphamide
IVIg with cyclophosphamide
cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
COMPLETED
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
IVIg Alone
IVIg alone
intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles
|
IVIg With Cyclophosphamide
IVIg with cyclophosphamide
cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Randomized Trial of IVIg With or Without Cyclophosphamide in Pemphigus
Baseline characteristics by cohort
| Measure |
Group A
n=5 Participants
IVIg alone
intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles
|
Group B
n=4 Participants
IVIg with cyclophosphamide
cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
61.2 years
n=5 Participants
|
56.25 years
n=7 Participants
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 - 10 weeks after initiation of therapyPopulation: Sadly, the trial PI, Dr. Jean-Claude Bystryn, died on August 19, 2010. As a result the study could not be completed and an analysis of the data collected was not performed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6-10 weeks after initiation of therapyPopulation: Sadly, the trial PI, Dr. Jean-Claude Bystryn, died on August 19, 2010. As a result the study could not be completed and an analysis of the data collected was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Throughout course of studyPopulation: Sadly, the trial PI, Dr. Jean-Claude Bystryn, died on August 19, 2010. As a result the study could not be completed and an analysis of the data collected was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured 6 and 10 weeks after initiation of IVIg treatmentPopulation: Sadly, the trial PI, Dr. Jean-Claude Bystryn, died on August 19, 2010. As a result the study could not be completed and an analysis of the data collected was not performed.
Outcome measures
Outcome data not reported
Adverse Events
Group A
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Group B
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A
n=5 participants at risk
IVIg alone
intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles
|
Group B
n=4 participants at risk
IVIg with cyclophosphamide
cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation not considered related to treatment
|
0.00%
0/5 • 3 years
|
25.0%
1/4 • Number of events 1 • 3 years
|
|
Cardiac disorders
Elevated blood pressure; blurred vision, nausea and tearing
|
20.0%
1/5 • Number of events 1 • 3 years
|
0.00%
0/4 • 3 years
|
Other adverse events
| Measure |
Group A
n=5 participants at risk
IVIg alone
intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles
|
Group B
n=4 participants at risk
IVIg with cyclophosphamide
cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
2/5 • Number of events 2 • 3 years
|
25.0%
1/4 • Number of events 1 • 3 years
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Number of events 1 • 3 years
|
25.0%
1/4 • Number of events 1 • 3 years
|
|
Cardiac disorders
Chest Tightness
|
20.0%
1/5 • Number of events 1 • 3 years
|
0.00%
0/4 • 3 years
|
|
Renal and urinary disorders
Increased Creatine Levels
|
20.0%
1/5 • Number of events 1 • 3 years
|
0.00%
0/4 • 3 years
|
|
Cardiac disorders
Hypertension
|
80.0%
4/5 • Number of events 4 • 3 years
|
0.00%
0/4 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Mild Muscle Pain
|
20.0%
1/5 • Number of events 1 • 3 years
|
25.0%
1/4 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Elevated Urine Protein Levels
|
40.0%
2/5 • Number of events 2 • 3 years
|
0.00%
0/4 • 3 years
|
|
Skin and subcutaneous tissue disorders
Localized minor inflammation
|
20.0%
1/5 • Number of events 1 • 3 years
|
0.00%
0/4 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmanary Adema
|
0.00%
0/5 • 3 years
|
25.0%
1/4 • Number of events 1 • 3 years
|
|
Infections and infestations
Oral Candida Infection
|
0.00%
0/5 • 3 years
|
25.0%
1/4 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
leukopenia
|
0.00%
0/5 • 3 years
|
25.0%
1/4 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Urinary Tract Infection
|
20.0%
1/5 • Number of events 1 • 3 years
|
25.0%
1/4 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Mild Nausea
|
20.0%
1/5 • Number of events 1 • 3 years
|
0.00%
0/4 • 3 years
|
|
Skin and subcutaneous tissue disorders
Mild skin infection
|
20.0%
1/5 • Number of events 1 • 3 years
|
0.00%
0/4 • 3 years
|
|
Skin and subcutaneous tissue disorders
Penile Ulcer
|
20.0%
1/5 • Number of events 1 • 3 years
|
0.00%
0/4 • 3 years
|
|
Nervous system disorders
Vasovega
|
20.0%
1/5 • Number of events 1 • 3 years
|
0.00%
0/4 • 3 years
|
|
Cardiac disorders
Angina
|
20.0%
1/5 • Number of events 1 • 3 years
|
0.00%
0/4 • 3 years
|
|
Injury, poisoning and procedural complications
Food Poisoning
|
20.0%
1/5 • Number of events 1 • 3 years
|
0.00%
0/4 • 3 years
|
|
Infections and infestations
Nail infection
|
0.00%
0/5 • 3 years
|
25.0%
1/4 • Number of events 1 • 3 years
|
Additional Information
Elise Kelman, Associate Director of Research Administration
NYU School of Medicine
Phone: 2122639073
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place