Trial · NCT00712348

Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase

NCT00712348, Phase 3, Completed, Pfizer; results first posted 2014-06-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase. Trials, record NCT00712348. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00712348

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase
NCT number: NCT00712348
Status: Completed
Phases: Phase 3
Enrollment: 31 participants, actual
Lead sponsor: Pfizer
Conditions: Gaucher Disease
Interventions: Taliglucerase alfa
First posted: 2008-07-10
Last updated: 2018-10-04
Results first posted: 2014-06-05

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Hemoglobin	Every 3 months from Baseline to Month 9
Other	Platelet Count	Every 3 months from Baseline to Month 9
Other	Spleen Volume	Baseline and 9 Months	Spleen volume measured by MRI in mL
Other	Liver Volume	Baseline and 9 months	Liver volume measured by MRI

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
OTHER_PRE_SPECIFIED	Platelet Count	Every 3 months from Baseline to Month 9		platelets/mm^3	MEAN
OTHER_PRE_SPECIFIED	Spleen Volume	Baseline and 9 Months	25 patients had spleen volume measured by MRI, 2 were MRI phobic and 3 were splenectomized	mL	MEAN
OTHER_PRE_SPECIFIED	Liver Volume	Baseline and 9 months	2 patients were MRI phobic	mL	MEAN
PRIMARY	Hemoglobin	Every 3 months from Baseline to Month 9		g/dL	MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Platelet Count	Taliglucerase Alfa	Baseline	161137	Standard Deviation 73387	platelets/mm^3
Platelet Count	Taliglucerase Alfa	Month 3	150800	Standard Deviation 66038	platelets/mm^3
Platelet Count	Taliglucerase Alfa	Month 6	157586	Standard Deviation 78357	platelets/mm^3
Platelet Count	Taliglucerase Alfa	Month 9	161167	Standard Deviation 80820	platelets/mm^3
Spleen Volume	Taliglucerase Alfa	Baseline	720.5	Standard Deviation 579.5	mL
Spleen Volume	Taliglucerase Alfa	Month 9	654.7	Standard Deviation 535.9	mL
Liver Volume	Taliglucerase Alfa	Baseline	1766	Standard Deviation 474.5	mL
Liver Volume	Taliglucerase Alfa	Month 9	1716	Standard Deviation 455.6	mL
Hemoglobin	Taliglucerase Alfa	Baseline	13.5	Standard Deviation 1.4	g/dL
Hemoglobin	Taliglucerase Alfa	Month 3	13.3	Standard Deviation 1.5	g/dL

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Taliglucerase Alfa	31
Overall Study	COMPLETED	Taliglucerase Alfa	30
Overall Study	NOT COMPLETED	Taliglucerase Alfa	1

Source ClinicalTrials.gov

Adverse events14

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	DIARRHOEA	Gastrointestinal disorders	Taliglucerase Alfa	2	31	2
other	PAIN	General disorders	Taliglucerase Alfa	2	31	2
other	NASOPHARYNGITIS	Infections and infestations	Taliglucerase Alfa	4	31	4
other	UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	Taliglucerase Alfa	3	31	3
other	URINARY TRACT INFECTION	Infections and infestations	Taliglucerase Alfa	3	31	3
other	INFUSION RELATED REACTION	Injury, poisoning and procedural complications	Taliglucerase Alfa	4	31	4
other	ARTHRALGIA	Musculoskeletal and connective tissue disorders	Taliglucerase Alfa	4	31	4
other	PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	Taliglucerase Alfa	3	31	3
other	HEADACHE	Nervous system disorders	Taliglucerase Alfa	4	31	4
other	COUGH	Respiratory, thoracic and mediastinal disorders	Taliglucerase Alfa	3	31	3

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Taliglucerase Alfa
Total, other adverse events	Taliglucerase Alfa	29	31
Total, serious adverse events	Taliglucerase Alfa	3	31

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24950666	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00712348

GET https://conductscience.org/api/trials/v1/NCT00712348/registered

API reference For AI assistants