Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00825149




Registration number
NCT00825149
Ethics application status
Date submitted
16/01/2009
Date registered
19/01/2009
Date last updated
4/11/2016

Titles & IDs
Public title
A Study of Obinutuzumab in Combination With Chemotherapy in Participants With CD20+ B-Cell Follicular Non-Hodgkin's Lymphoma
Scientific title
An Open-Label, Multi-Centre, Randomised, Phase Ib Study to Investigate the Safety and Efficacy of RO5072759 Given in Combination With CHOP, FC or Bendamustine Chemotherapy in Patients With CD20+ B-Cell Follicular Non-Hodgkin's Lymphoma
Secondary ID [1] 0 0
2008-001643-19
Secondary ID [2] 0 0
BO21000
Universal Trial Number (UTN)
Trial acronym
GAUDI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Hodgkin's Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bendamustine
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Fludarabine
Treatment: Drugs - Obinutuzumab
Treatment: Drugs - Prednisone
Treatment: Drugs - Vincristine

Experimental: A: R/R FL: Obinutuzumab Low Dose + CHOP - Participants with Relapsed/Refractory (R/R) FL will receive obinutuzumab 400 milligrams (mg) intravenous (IV) infusion on Days 1 and 8 of Cycle 1 and every 3 weeks on Day 1 of subsequent cycles (for 68 cycles) in the induction period; Prednisone 100 mg/day orally on Days 15, doxorubicin 50 milligrams per square-meter (mg/m\^2), vincristine 1.4 mg/m\^2 capped at 2 mg, and cyclophosphamide 750 mg/m\^2 IV infusion every 3 weeks on Day 1 of each cycle for 68 cycles in the induction period. 12 weeks following last infusion, participants with CR or PR will be eligible to receive 400 mg obinutuzumab IV infusion once every 3 months for 2 years or until disease progression in the maintenance period.

Experimental: B: R/R FL: Obinutuzumab High Dose + CHOP - Participants with R/R FL will receive obinutuzumab 1600 mg IV infusion on Days 1 and 8 of Cycle 1 and 800 mg IV infusion every 3 weeks on Day 1 of subsequent cycles (for 68 cycles) in the induction period; Prednisone 100 mg/day orally on Days 15, doxorubicin 50 mg/m\^2, vincristine 1.4 mg/m\^2 capped at 2 mg, and cyclophosphamide 750 mg/m\^2 IV infusion every 3 weeks on Day 1 of each cycle for 68 cycles in the induction period. 12 weeks following last infusion, participants with CR or PR will be eligible to receive 800 mg obinutuzumab IV infusion once every 3 months for 2 years or until disease progression in the maintenance period.

Experimental: C: R/R FL: Obinutuzumab Low Dose + FC - Participants with R/R FL will receive obinutuzumab 400 mg IV infusion on Days 1 and 8 of Cycle 1 and every 4 weeks on Day 1 of subsequent cycles (for 46 cycles) in the induction period; Fludarabine 25 mg/m\^2/day and cyclophosphamide 250 mg/m\^2/day IV infusion every 4 weeks on Days 13 of each cycle for 46 cycles in the induction period. 12 weeks following last infusion, participants with CR or PR will be eligible to receive 400 mg obinutuzumab IV infusion once every 3 months for 2 years or until disease progression in the maintenance period.

Experimental: D: R/R FL: Obinutuzumab High Dose + FC - Participants with R/R FL will receive obinutuzumab 1600 mg IV infusion on Days 1 and 8 of Cycle 1 and 800 mg IV infusion every 4 weeks on Days 1 of subsequent cycles (for 46 cycles) in the induction period; Fludarabine 25 mg/m\^2/day and cyclophosphamide 250 mg/m\^2/day IV infusion every 4 weeks on Days 13 of each cycle for 46 cycles in the induction period. 12 weeks following last infusion, participants with CR or PR will be eligible to receive 800 mg obinutuzumab IV infusion once every 3 months for 2 years or until disease progression in the maintenance period.

Experimental: E: First-Line FL: Obinutuzumab + Bendamustine - Participants with first-line FL will receive obinutuzumab 1000 mg IV infusion on Days 1 and 8 of Cycle 1 and every 4 weeks on Day 1 of subsequent cycles (for 46 cycles) in the induction period; Bendamustine 90 mg/m\^2 IV infusion on Days 2 and 3 of Cycle 1 and every 4 weeks on Days 1 and 2 of each subsequent cycle for 46 cycles in the induction period. 12 weeks following last infusion, participants with CR or PR will be eligible to receive 1000 mg obinutuzumab IV infusion once every 3 months for 2 years or until disease progression in the maintenance period.

Experimental: F: First-Line FL: Obinutuzumab + CHOP - Participants with first-line FL will receive obinutuzumab 1000 mg IV infusion on Days 1 and 8 of Cycle 1 and every 3 weeks on Day 1 of subsequent cycles (for 68 cycles) in the induction period; Prednisone 100 mg/day orally on Days 15, doxorubicin 50 mg/m\^2, vincristine 1.4 mg/m\^2 capped at 2 mg, cyclophosphamide 750 mg/m\^2 IV infusion every 3 weeks on Day 1 of each cycle for 68 cycles in the induction period. 12 weeks following last infusion, participants with CR or PR will be eligible to receive 1000 mg obinutuzumab IV infusion once every 3 months for 2 years or until disease progression in the maintenance period.


Treatment: Drugs: Bendamustine
Bendamustine will be administered as per schedule specified in the respective arm.

Treatment: Drugs: Cyclophosphamide
Cyclophosphamide will be administered as per schedule specified in the respective arm.

Treatment: Drugs: Doxorubicin
Doxorubicin will be administered as per schedule specified in the respective arm.

Treatment: Drugs: Fludarabine
Fludarabine will be administered as per schedule specified in the respective arm.

Treatment: Drugs: Obinutuzumab
Obinutuzumab will be administered as per schedule specified in the respective arm.

Treatment: Drugs: Prednisone
Prednisone will be administered as per schedule specified in the respective arm.

Treatment: Drugs: Vincristine
Vincristine will be administered as per schedule specified in the respective arm.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Adverse Events (AEs) - Relapsed/Refractory Population
Timepoint [1] 0 0
Baseline up to maximum observation time of 79.5 months
Primary outcome [2] 0 0
Percentage of Participants With AEs - First-line Population
Timepoint [2] 0 0
Baseline up to maximum observation time of 59.7 months
Secondary outcome [1] 0 0
Percentage of Participants With End of Induction Response, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - Relapsed/Refractory Population
Timepoint [1] 0 0
28 days after end of induction treatment (up to 28 weeks)
Secondary outcome [2] 0 0
Percentage of Participants With End of Induction Response, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - First-line Population
Timepoint [2] 0 0
28 days after end of induction treatment (up to 28 weeks)
Secondary outcome [3] 0 0
Percentage of Participants With Best Overall Response, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - Relapsed/Refractory Population
Timepoint [3] 0 0
Baseline up to initiation of new anti-lymphoma therapy or end of study (up to a maximum observation time of 79.5 months)
Secondary outcome [4] 0 0
Percentage of Participants With Best Overall Response, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - First-line Population
Timepoint [4] 0 0
Baseline up to initiation of new anti-lymphoma therapy or end of study (up to a maximum observation time of 59.7 months)
Secondary outcome [5] 0 0
Percentage of Participants With Best Overall Response of Complete Response, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - Relapsed/Refractory Population
Timepoint [5] 0 0
Baseline up to initiation of new anti-lymphoma therapy or end of study (up to a maximum observation time of 79.5 months)
Secondary outcome [6] 0 0
Percentage of Participants With Best Overall Response of Complete Response, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - First-line Population
Timepoint [6] 0 0
Baseline up to initiation of new anti-lymphoma therapy or end of study (up to a maximum observation time of 59.7 months)
Secondary outcome [7] 0 0
Number of Participants With Progression-Free Survival (PFS) Events (Disease Progression/Relapse or Death), According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - Relapsed/Refractory Population
Timepoint [7] 0 0
Baseline up to disease progression or death (up to maximum observation time of 79.5 months)
Secondary outcome [8] 0 0
Number of Participants With PFS Events (Disease Progression/Relapse or Death), According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - First-line Population
Timepoint [8] 0 0
Baseline up to disease progression or death (up to maximum observation time of 59.7 months)
Secondary outcome [9] 0 0
PFS, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - Relapsed/Refractory Population
Timepoint [9] 0 0
Baseline up to disease progression or death (up to maximum observation time of 79.5 months)
Secondary outcome [10] 0 0
PFS, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - First-line Population
Timepoint [10] 0 0
Baseline up to disease progression or death (up to maximum observation time of 59.7 months)
Secondary outcome [11] 0 0
Number of Participants With Event-Free Survival (EFS) Event (Disease Progression, Death, or Initiation of a New Anti-Lymphoma Therapy), According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - Relapsed/Refractory Population
Timepoint [11] 0 0
Baseline up to disease progression or death or new anti-lymphoma treatment (up to maximum observation time of 79.5 months)
Secondary outcome [12] 0 0
Number of Participants With EFS Event (Disease Progression, Death, or Initiation of a New Anti-Lymphoma Therapy), According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - Relapsed/Refractory Population
Timepoint [12] 0 0
Baseline up to disease progression or death or new anti-lymphoma treatment (up to maximum observation time of 59.7 months)
Secondary outcome [13] 0 0
EFS, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - Relapsed/Refractory Population
Timepoint [13] 0 0
Baseline up to disease progression or death or new anti-lymphoma treatment (up to maximum observation time of 79.5 months)
Secondary outcome [14] 0 0
EFS, According to 2007 Revised Response Criteria for Non Hodgkin's lymphoma - First-line Population
Timepoint [14] 0 0
Baseline up to disease progression or death or new anti-lymphoma treatment (up to maximum observation time of 79.5 months)
Secondary outcome [15] 0 0
Pharmacokinetics of Obinutuzumab: Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) - Relapsed/Refractory Population
Timepoint [15] 0 0
Day 1 (Pre-infusion [0 hour {hr}], end of infusion [EOI, approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 21 or 28 days); end of induction (28 days after last infusion) (up to 28 months)
Secondary outcome [16] 0 0
Pharmacokinetics of Obinutuzumab: AUClast - First-line Population
Timepoint [16] 0 0
Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 28 days); end of induction (28 days after last infusion) (up to 28 months)
Secondary outcome [17] 0 0
Pharmacokinetics of Obinutuzumab: Maximum Observed Plasma Concentration (Cmax) - Relapsed/Refractory Population
Timepoint [17] 0 0
Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 21 or 28 days); end of induction (28 days after last infusion) (up to 28 months)
Secondary outcome [18] 0 0
Pharmacokinetics of Obinutuzumab: Cmax - First-line Population
Timepoint [18] 0 0
Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 28 days); end of induction (28 days after last infusion) (up to 28 months)
Secondary outcome [19] 0 0
Pharmacokinetics of Obinutuzumab: Systemic Clearance at Steady State (CLss) - Relapsed/Refractory Population
Timepoint [19] 0 0
Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 21 or 28 days); end of induction (28 days after last infusion) (up to 28 months)
Secondary outcome [20] 0 0
Pharmacokinetics of Obinutuzumab: CLss - First-line Population
Timepoint [20] 0 0
Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 28 days); end of induction (28 days after last infusion) (up to 28 months)
Secondary outcome [21] 0 0
Pharmacokinetics of Obinutuzumab: AUC From Time Zero to 7 Days (AUC7d) - Relapsed/Refractory Population
Timepoint [21] 0 0
Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 21 or 28 days); end of induction (28 days after last infusion) (up to 28 months)
Secondary outcome [22] 0 0
Pharmacokinetics of Obinutuzumab: AUC7d - First-line Population
Timepoint [22] 0 0
Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 28 days); end of induction (28 days after last infusion) (up to 28 months)
Secondary outcome [23] 0 0
Pharmacokinetics of Obinutuzumab: Volume of Distribution at Steady State (Vss) - Relapsed/Refractory Population
Timepoint [23] 0 0
Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 21 or 28 days); end of induction (28 days after last infusion) (up to 28 months)
Secondary outcome [24] 0 0
Pharmacokinetics of Obinutuzumab: Vss - First-line Population
Timepoint [24] 0 0
Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 28 days); end of induction (28 days after last infusion) (up to 28 months)
Secondary outcome [25] 0 0
Pharmacokinetics of Obinutuzumab: Plasma Half-life (t1/2) - Relapsed/Refractory Population
Timepoint [25] 0 0
Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 21 or 28 days); end of induction (28 days after last infusion) (up to 28 months)
Secondary outcome [26] 0 0
Pharmacokinetics of Obinutuzumab: t1/2 - First-line Population
Timepoint [26] 0 0
Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 28 days); end of induction (28 days after last infusion) (up to 28 months)
Secondary outcome [27] 0 0
Pharmacokinetics of Obinutuzumab: Plasma Trough Concentration (Ctrough) - Relapsed/Refractory Population
Timepoint [27] 0 0
Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 21 or 28 days); end of induction (28 days after last infusion) (up to 28 months)
Secondary outcome [28] 0 0
Pharmacokinetics of Obinutuzumab: Ctrough - First-line Population
Timepoint [28] 0 0
Day 1 (Pre-infusion [0 hr], EOI [approximately 6 hr], 3-6 hr post-infusion), Day 8 (Pre-infusion [0 hr], EOI) of Cycle 1 (1 Cycle = 28 days); end of induction (28 days after last infusion) (up to 28 months)
Secondary outcome [29] 0 0
Pharmacodynamics of Obinutuzumab: Number of Participants With Peripheral Blood B-cell Depletion - Relapsed/Refractory Population
Timepoint [29] 0 0
Cycle 1 Day 1 up to end of treatment (up to the maximum observation time of 79.5 months)
Secondary outcome [30] 0 0
Pharmacodynamics of Obinutuzumab: Number of Participants With Peripheral Blood B-cell Depletion - First-line Population
Timepoint [30] 0 0
Cycle 1 Day 1 up to end of treatment (up to the maximum observation time of 59.7 months)
Secondary outcome [31] 0 0
Pharmacodynamics of Obinutuzumab: Time From End of Treatment to B-Cell Recovery - Relapsed/Refractory Population
Timepoint [31] 0 0
From end of treatment to B-cell recovery (up to the maximum observation time of 79.5 months)
Secondary outcome [32] 0 0
Pharmacodynamics of Obinutuzumab: Time From End of Treatment to B-Cell Recovery - First-line Population
Timepoint [32] 0 0
From end of treatment to B-cell recovery (up to the maximum observation time of 59.7 months)

Eligibility
Key inclusion criteria
* Either CD20+ R/R B-cell follicular non-Hodgkin's lymphoma (after a maximum of 2 prior chemotherapy regimens) or CD20+ B-cell follicular non-Hodgkin's lymphoma with no prior systemic therapy
* Must have at least one bi-dimensionally measurable lesion (greater than [>] 1.5 centimeters [cm] in its largest dimension by computed tomography [CT] scan)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* For R/R participants recruited in Obinutuzumab + CHOP regimen, prior use of anthracyclines. For R/R participants recruited in Obinutuzumab + FC regimen, immediate prior treatment should not have contained fludarabine or fluoropyrimidines. For first-line recruited participants, prior systemic therapy
* Prior administration of rituximab within 56 days of study entry, or 3 months for any radioimmunotherapy
* Central nervous system lymphoma
* History of other malignancies within 2 years of study entry which could affect compliance with the protocol or interpretation of results
* Known active bacterial, viral (including human immunodeficiency virus [HIV]), fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of dosing
* Contraindication to any of the individual components of chemotherapy (as per local prescribing information), of the selected chemotherapy combination (FC, CHOP or bendamustine)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2015
Sample size
Target
Accrual to date
Final
137
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
- Kogarah
Recruitment hospital [2] 0 0
- Sydney
Recruitment hospital [3] 0 0
- Greenslopes
Recruitment hospital [4] 0 0
- Woolloongabba
Recruitment hospital [5] 0 0
- Kurralta Park
Recruitment hospital [6] 0 0
- Frankston
Recruitment hospital [7] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2145 - Sydney
Recruitment postcode(s) [3] 0 0
4120 - Greenslopes
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [6] 0 0
3199 - Frankston
Recruitment postcode(s) [7] 0 0
3000 - Melbourne
Recruitment postcode(s) [8] 0 0
3084 - Melbourne
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Lille
Country [2] 0 0
France
State/province [2] 0 0
Montpellier
Country [3] 0 0
France
State/province [3] 0 0
Pierre Benite
Country [4] 0 0
Germany
State/province [4] 0 0
Aschaffenburg
Country [5] 0 0
Germany
State/province [5] 0 0
Freiburg
Country [6] 0 0
Germany
State/province [6] 0 0
Göttingen
Country [7] 0 0
Germany
State/province [7] 0 0
Heidelberg
Country [8] 0 0
Germany
State/province [8] 0 0
Kiel
Country [9] 0 0
Germany
State/province [9] 0 0
Köln
Country [10] 0 0
Germany
State/province [10] 0 0
Muenchen
Country [11] 0 0
Germany
State/province [11] 0 0
Ulm
Country [12] 0 0
Germany
State/province [12] 0 0
Würzburg
Country [13] 0 0
Italy
State/province [13] 0 0
Lazio
Country [14] 0 0
Italy
State/province [14] 0 0
Lombardia
Country [15] 0 0
Italy
State/province [15] 0 0
Piemonte
Country [16] 0 0
Spain
State/province [16] 0 0
Barcelona
Country [17] 0 0
Spain
State/province [17] 0 0
Salamanca
Country [18] 0 0
Spain
State/province [18] 0 0
Valencia
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Leicester
Country [20] 0 0
United Kingdom
State/province [20] 0 0
London
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Manchester
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Plymouth
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Southampton
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00825149