Valproic Acid With Methylprenisonlone for the Treatment o... | NCT02848105

Studies
Valproic Acid With Methylprenisonlone for the Treatment of Acute GVHD

NCT02848105

Sponsor

Shanghai Jiao Tong University School of Medicine

Status

Unknown status

Last Update Posted

Aug 1, 2016Estimated

Enrollment

55Estimated

Phase

Phase 2

Conditions

Peripheral Blood Stem Cell Transplantation
aGVHD

Interventions

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016

Primary Completion Date

Jul 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Jul 26, 2016

First Submission Date that Met QC Criteria

Jul 26, 2016

First Posted Date

Jul 28, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2016

Last Update Posted Date

Aug 1, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jiong HU, Head, Blood and Marrow Transplantation Program, Shanghai Jiao Tong University School of MedicinePrincipal Investigator

Lead Sponsor

Shanghai Jiao Tong University School of MedicineOTHER

Collaborators

Name	Class
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

aGVHD remains as complication in patients after allogeneic stem cell transplantation. Methylprednisolone at 1~2mg/kg is considered as standard first-line treatment. In recent lab study, we demonstrated that valproic acid (VPA) as histone deacetylase inhibitor can inhibit CD4+ Th1 and Th17 cells and control the aGVDH in mice model while preserve the GVL effects. In this study, we tested the hypothesis that adding VPA to standard dose steroid treatment may improve the outcome of aGVHD.

Detailed Description

To evaluate the complete response rate of VPA+Methylpednisolone in patients with Grade II-IV aGVHD after allogenetic stem cell transplantation.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

55Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VPA+Methyl	Experimental	VPA added to standard methylpredisonlone treatment for aGVHD	Drug: VPA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VPA	Drug	Valproic acid with 1000mg loading dose with 500mg q12 4 hours later to maintain a trough level above 75ug/ml	VPA+Methyl

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
complete response		28 days after the treatment

Secondary Outcomes

Measure	Description	Time Frame
Overall response (complete + partial response)		28 days after the treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Grade II-IV aGVHD
No previous history of allergy to valproic acid
No active and severe infection

Exclusion Criteria:

Inclusion in other clinical trial
GVHD Prophylaxis with valproic acid
severe organ dysfunction: heart, lung, liver and kidney

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jiong HU, M.D.,	Contact			hujiong@medmail.com.cn
Ling Wang, M.D.,	Contact			cclingjar@163.com

Overall Officials

Name	Affiliation	Role
Jiong HU, M.D.,	Shanghai Jiao Tong University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Blood & Marrow Transplantation Center, RuiJin Hospital	Recruiting	Shanghai	Shanghai Municipality	200025	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided