Trial · NCT00483119
Randomized Trial of IVIg With or Without Cyclophosphamide in Pemphigus
NCT00483119, Phase 2, Terminated, NYU Langone Health; results first posted 2016-02-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Randomized Trial of IVIg With or Without Cyclophosphamide in Pemphigus. Trials, record NCT00483119. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00483119
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Trial of IVIg With or Without Cyclophosphamide in Pemphigus
- NCT number
- NCT00483119
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- NYU Langone Health
- Conditions
- Pemphigus Vulgaris
- Interventions
- intravenous immunoglobulin, cyclophosphamide
- First posted
- 2007-06-06
- Last updated
- 2016-02-18
- Results first posted
- 2016-02-18
- Limitations and caveats
- 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.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Outcome: Extent and Severity of Disease | 6 - 10 weeks after initiation of therapy | |
| Primary | Serum Levels of Pemphigus Antibodies | 6-10 weeks after initiation of therapy | |
| Secondary | Toxicity of Treatment: Measured in Renal Toxicity, Myelosuppression or Hepatic Toxicity | Throughout course of study | |
| Secondary | Ability to be Weaned Off Steroids | Measured 6 and 10 weeks after initiation of IVIg treatment |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Outcome: Extent and Severity of Disease | 6 - 10 weeks after initiation of therapy | 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. | ||
| PRIMARY | Serum Levels of Pemphigus Antibodies | 6-10 weeks after initiation of therapy | 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. | ||
| SECONDARY | Toxicity of Treatment: Measured in Renal Toxicity, Myelosuppression or Hepatic Toxicity | Throughout course of study | 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. | ||
| SECONDARY | Ability to be Weaned Off Steroids | Measured 6 and 10 weeks after initiation of IVIg treatment | 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. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IVIg Alone | 5 | |
| Overall Study | STARTED | IVIg With Cyclophosphamide | 4 | |
| Overall Study | COMPLETED | IVIg Alone | 4 | |
| Overall Study | COMPLETED | IVIg With Cyclophosphamide | 3 | |
| Overall Study | NOT COMPLETED | IVIg Alone | 1 | |
| Overall Study | NOT COMPLETED | IVIg With Cyclophosphamide | 1 |
Source ClinicalTrials.gov
Adverse events42
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Group A | 2 | 5 | 2 |
| other | Anemia | Blood and lymphatic system disorders | Group B | 1 | 4 | 1 |
| other | Headache | Nervous system disorders | Group A | 1 | 5 | 1 |
| other | Headache | Nervous system disorders | Group B | 1 | 4 | 1 |
| other | Chest Tightness | Cardiac disorders | Group A | 1 | 5 | 1 |
| other | Chest Tightness | Cardiac disorders | Group B | 0 | 4 | 0 |
| other | Increased Creatine Levels | Renal and urinary disorders | Group A | 1 | 5 | 1 |
| other | Increased Creatine Levels | Renal and urinary disorders | Group B | 0 | 4 | 0 |
| other | Hypertension | Cardiac disorders | Group A | 4 | 5 | 4 |
| other | Hypertension | Cardiac disorders | Group B | 0 | 4 | 0 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A | ||
| Total, all-cause mortality | Group B | ||
| Total, other adverse events | Group A | 5 | 5 |
| Total, other adverse events | Group B | 4 | 4 |
| Total, serious adverse events | Group A | 1 | 5 |
| Total, serious adverse events | Group B | 1 | 4 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Group A vs Group B: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00483119
GET https://conductscience.org/api/trials/v1/NCT00483119/events?page=2