Trial · NCT02843035
Venglustat in Combination With Cerezyme in Adult Patients With Gaucher Disease Type 3 With Venglustat Monotherapy Extension
NCT02843035, Phase 2, Active not recruiting, Genzyme, a Sanofi Company
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Venglustat in Combination With Cerezyme in Adult Patients With Gaucher Disease Type 3 With Venglustat Monotherapy Extension. Trials, record NCT02843035. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02843035
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Venglustat in Combination With Cerezyme in Adult Patients With Gaucher Disease Type 3 With Venglustat Monotherapy Extension
- NCT number
- NCT02843035
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- Genzyme, a Sanofi Company
- Conditions
- Gaucher Disease Type 1, Gaucher Disease Type 3
- Interventions
- venglustat (GZ402671), imiglucerase
- First posted
- 2016-07-25
- Last updated
- 2026-07-10
- Other registries' IDs
- eudract:2014-002550-39
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with Treatment Emergent Adverse Events (TEAEs) | From screening up to end of study, up to approximately 10 years | |
| Primary | Assessment of pharmacodynamic (PD) parameter: Lyso-glucosylceramide (lyso-GL1) and glucosylceramide (GL-1) in cerebrospinal fluid (CSF) | From screening through Week 52 | |
| Secondary | Assessment of pharmacodynamic (PD) parameter: Lyso-glucosylceramide (lyso-GL1) and glucosylceramide (GL-1) in plasma | From screening up to end of study, up to approximately 10 years | Change from baseline in plasma lyso-GL1 and GL1 |
| Secondary | Assessment of plasma pharmacokinetic parameter: Cmax (Part 2) | Day 1 | Plasma maximum concentration (Cmax) |
| Secondary | Assessment of plasma pharmacokinetic parameter: Tmax (Part 2) | Day 1 | Plasma time at Cmax (Tmax) |
| Secondary | Assessment of plasma pharmacokinetic parameter: AUC0-24h (Part 2) | Day 1 | Plasma area under the curve (AUC0-24h) |
| Secondary | Assessment of plasma pharmacokinetic parameter: Ctrough | Weeks 12 and 39 (Part 2), and on Weeks 78, 104, and 156 (for Part 3) | Plasma trough concentration (Ctrough) |
| Secondary | Assessment of CSF pharmacokinetic parameter: Cmax | Week 4, Week 26, and Week 52 | CSF maximum concentration (Cmax) |
| Secondary | Assessment of spleen volume | From screening up to end of study, up to approximately 10 years | Percent change from baseline in spleen volume assessed by Magnetic Resonance Imaging (MRI) |
| Secondary | Assessment of spleen volume (Part 4) | From Week 260 up to end of study, up to approximately 10 years | Percent change from Part 4 baseline in spleen volume assessed by MRI |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38802634 | DERIVED |
Source PubMed
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/NCT02843035
GET https://conductscience.org/api/trials/v1/NCT02843035/registered