Trial · NCT00705939

Plant Cell Expressed Recombinant Human Glucocerebrosidase Extension Trial

NCT00705939, Phase 3, Completed, Pfizer; results first posted 2014-07-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Plant Cell Expressed Recombinant Human Glucocerebrosidase Extension Trial. Trials, record NCT00705939. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00705939

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Trial

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

Title: Plant Cell Expressed Recombinant Human Glucocerebrosidase Extension Trial
NCT number: NCT00705939
Status: Completed
Phases: Phase 3
Enrollment: 45 participants, actual
Lead sponsor: Pfizer
Conditions: Gaucher Disease
Interventions: Taliglucerase alfa
First posted: 2008-06-27
Last updated: 2018-10-04
Results first posted: 2014-07-15

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Spleen Volume	Spleen Volume at Baseline and Months 12, 24, and 36	Spleen volume measured by MRI
Secondary	Liver Volume	Liver volume at Baseline and Months 12, 24 and 36	Liver volume measured by MRI
Secondary	Hemoglobin	Hemoglobin at Baseline and Months 12, 24 and 36
Secondary	Platelet Count	Platelet count at Baseline and Months 12, 24 and 36
Other	Spleen Volume Multiples of Normal (MN)	Baseline and Months 12, 24, and 36	Spleen volume measured by MRI. Normal spleen volume is 2 mL/kg × body weight (kg)
Other	Liver Volume Multiples of Normal (MN)	Baseline and Months 12, 24 and 36	Liver volume measured by MRI. Normal liver volume is 25 mL/kg × body weight (kg).

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Spleen Volume	Spleen Volume at Baseline and Months 12, 24, and 36	Intent to treat. In the Switchover group, two patients did not have MRI and one patient was splenectomized.	mL	MEAN
SECONDARY	Liver Volume	Liver volume at Baseline and Months 12, 24 and 36	Intent to treat. In the Switchover group, two patients did not have MRI .	mL	MEAN
OTHER_PRE_SPECIFIED	Spleen Volume Multiples of Normal (MN)	Baseline and Months 12, 24, and 36	Intent to treat. In the Switchover group, two patients did not have MRI and one patient was splenectomized.	Multiples of Normal Spleen Volume	MEAN
OTHER_PRE_SPECIFIED	Liver Volume Multiples of Normal (MN)	Baseline and Months 12, 24 and 36	Intent to treat. In the Switchover group, two patients did not have MRI.	Multiples of Normal Liver Volume	MEAN
SECONDARY	Hemoglobin	Hemoglobin at Baseline and Months 12, 24 and 36		mg/dL	MEAN
SECONDARY	Platelet Count	Platelet count at Baseline and Months 12, 24 and 36		Platelets per cubic millimeter	MEAN

Source ClinicalTrials.gov

Results by group72

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

Outcome	Group	Category	Value	Spread	Units
Spleen Volume	Naive 30 Units/kg	Baseline	2324.0	Standard Deviation 1209.0	mL
Spleen Volume	Naive 60 Units/kg	Baseline	2120.0	Standard Deviation 1426.5	mL
Spleen Volume	Switchover	Baseline	778.0	Standard Deviation 666.3	mL
Spleen Volume	Naive 30 Units/kg	Month 12	1707.7	Standard Deviation 1069.5	mL
Spleen Volume	Naive 60 Units/kg	Month 12	1267.9	Standard Deviation 1114.1	mL
Spleen Volume	Switchover	Month 12	883.7	Standard Deviation 760.0	mL
Spleen Volume	Naive 30 Units/kg	Month 24	1420.4	Standard Deviation 852.3	mL
Spleen Volume	Naive 60 Units/kg	Month 24	946.7	Standard Deviation 699.6	mL
Spleen Volume	Switchover	Month 24	609.1	Standard Deviation 442.7	mL
Spleen Volume	Naive 30 Units/kg	Month 36	1237.2	Standard Deviation 695.7	mL

1 to 10 of 72Source ClinicalTrials.gov

See all 72 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Naive 30 Units/kg	12
Overall Study	STARTED	Naive 60 Units/kg	14
Overall Study	STARTED	Switchover	18
Overall Study	COMPLETED	Naive 30 Units/kg	12
Overall Study	COMPLETED	Naive 60 Units/kg	12
Overall Study	COMPLETED	Switchover	14
Overall Study	NOT COMPLETED	Naive 30 Units/kg	0
Overall Study	NOT COMPLETED	Naive 60 Units/kg	2
Overall Study	NOT COMPLETED	Switchover	4

Source ClinicalTrials.gov

Adverse events108

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	ARTHRALGIA	Musculoskeletal and connective tissue disorders	Naive 30 Units/kg	4	12	4
other	ARTHRALGIA	Musculoskeletal and connective tissue disorders	Naive 60 Units/kg	4	14	4
other	ARTHRALGIA	Musculoskeletal and connective tissue disorders	Switchover	4	18	4
other	BACK PAIN	Musculoskeletal and connective tissue disorders	Naive 30 Units/kg	2	12	2
other	BACK PAIN	Musculoskeletal and connective tissue disorders	Naive 60 Units/kg	2	14	2
other	BACK PAIN	Musculoskeletal and connective tissue disorders	Switchover	2	18	2
other	COUGH	Respiratory, thoracic and mediastinal disorders	Naive 30 Units/kg	0	12	0
other	COUGH	Respiratory, thoracic and mediastinal disorders	Naive 60 Units/kg	1	14	1
other	COUGH	Respiratory, thoracic and mediastinal disorders	Switchover	3	18	3
other	DIARRHOEA	Gastrointestinal disorders	Naive 30 Units/kg	3	12	3

1 to 10 of 108Source ClinicalTrials.gov

See all 108 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Naive 30 Units/kg
Total, all-cause mortality	Naive 60 Units/kg
Total, all-cause mortality	Switchover
Total, other adverse events	Naive 30 Units/kg	12	12
Total, other adverse events	Naive 60 Units/kg	12	14
Total, other adverse events	Switchover	17	18
Total, serious adverse events	Naive 30 Units/kg	2	12
Total, serious adverse events	Naive 60 Units/kg	2	14
Total, serious adverse events	Switchover	3	18

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27102949	DERIVED	PubMed
27174694	DERIVED	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/NCT00705939

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