Trial · NCT00605657
Valproic Acid (Depakote[Registered Trademark]) to Treat Autoimmune Lymphoproliferative Syndrome (ALPS)
NCT00605657, Phase 1, Phase 2, Completed, Koneti Rao; results first posted 2013-03-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Valproic Acid (Depakote[Registered Trademark]) to Treat Autoimmune Lymphoproliferative Syndrome (ALPS). Trials, record NCT00605657. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00605657
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Valproic Acid (Depakote[Registered Trademark]) to Treat Autoimmune Lymphoproliferative Syndrome (ALPS)
- NCT number
- NCT00605657
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- Koneti Rao
- Conditions
- ALPS, Hypersplenism, Lymphadenopathy
- Interventions
- Valproic Acid, CT Scan, Blood Sample
- First posted
- 2008-01-31
- Last updated
- 2013-03-21
- Results first posted
- 2013-03-21
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Response | 3 monthly (12 week) intervals | Reduction of lymph node and/or spleen size measured by CT imaging, or physical exam and abdominal ultrasound. A clinical response is defined as a greater than 40% reduction in lymph node size and/or greater than 40% reduction in spleen size. A CT scan with contrast measured lymph node size as well as spleen size. |
| Secondary | To Determine Whether the Treatment Alters, in Favorable Directions, Laboratory Markers of ALPS (e.g., Number of DNT Cells, Immunoglobin Levels, Vitamin B12 Levels, IL-10 Levels, Autoantibody Titers, Fas Mediated Apoptosis) | 3 monthly (12 week) intervals |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Response | 3 monthly (12 week) intervals | participants | NUMBER | |
| SECONDARY | To Determine Whether the Treatment Alters, in Favorable Directions, Laboratory Markers of ALPS (e.g., Number of DNT Cells, Immunoglobin Levels, Vitamin B12 Levels, IL-10 Levels, Autoantibody Titers, Fas Mediated Apoptosis) | 3 monthly (12 week) intervals | outcome measure not assessed because 0 participants had a response |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Response | Valproic Acid | 0 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Valproic Acid | 5 | |
| Overall Study | COMPLETED | Valproic Acid | 3 | |
| Overall Study | NOT COMPLETED | Valproic Acid | 2 |
Source ClinicalTrials.gov
Adverse events22
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 | fever | General disorders | Valproic Acid | 2 | 5 | 2 |
| other | decreased platelets | Blood and lymphatic system disorders | Valproic Acid | 3 | 5 | 3 |
| other | decreased hemoglobin | Blood and lymphatic system disorders | Valproic Acid | 3 | 5 | 3 |
| other | decreased neutrophil count | Blood and lymphatic system disorders | Valproic Acid | 4 | 5 | 4 |
| other | hyperglycemia | General disorders | Valproic Acid | 1 | 5 | 1 |
| other | vomiting | Gastrointestinal disorders | Valproic Acid | 1 | 5 | 1 |
| other | cough | Respiratory, thoracic and mediastinal disorders | Valproic Acid | 2 | 5 | 2 |
| other | sinus congestion | Respiratory, thoracic and mediastinal disorders | Valproic Acid | 2 | 5 | 2 |
| other | fatigue | General disorders | Valproic Acid | 5 | 5 | 5 |
| other | rhinorrhea | General disorders | Valproic Acid | 1 | 5 | 1 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Valproic Acid | ||
| Total, other adverse events | Valproic Acid | 5 | 5 |
| Total, serious adverse events | Valproic Acid | 1 | 5 |
Source ClinicalTrials.gov
Papers3
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00605657
GET https://conductscience.org/api/trials/v1/NCT00605657/events?page=2