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Treatment of Intravenous Infusion Plasma in Amyotrophic Lateral Sclerosis

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Completed
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Plasma from healthy young people treatment + Riluzole
Riluzole
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring Amyotrophic lateral sclerosis; Plasma infusion

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Meet the following diagnosis standard: confirmed, proposed and laboratory supported diagnosis;
  • Age 50-70 years old ;
  • 3-18 months course of disease;
  • Forced vital capacity (FVC) ≥70% predicted value;
  • Total amyotrophic lateral sclerosis Functional Rating Scale score ≥36, scores of respiratory related items ≥10;
  • Take Riluzole regularly before participate in this trial (25~50mg twice a day for at least 30 days continuously) without obvious side effects and can continue to take for 22 months;
  • Participants of childbearing age take reasonable and effective contraceptive measures from the time of enrollment to the end of follow-up;
  • Signed informed consent.

Exclusion Criteria:

  • Familial amyotrophic lateral sclerosis;
  • Female during pregnancy and lactation;
  • Positive hepatitis B, hepatitis C or HIV in screening
  • History of cytomegalovirus and malaria infection;
  • After tracheotomy and ventilator-dependent state (daily use of non-invasive ventilator ≥ 22 hours for 7 consecutive days);
  • After percutaneous gastrostomy (PEG) operation;
  • Has had allergic reactions and other adverse reactions during blood transfusion;
  • Have diseases of the blood system (including Immunoglobulin A deficiency);
  • alanine transaminase, Aspartate transaminase≥ 3 times the upper limit of normal;
  • Abnormal renal function (Cr, BUN);
  • History of malignant tumors;
  • Combining severe cardiopulmonary diseases, autoimmune diseases, mental diseases, substance abuse history, etc;
  • Currently participating in other clinical studies or using other drugs in researching.

Sites / Locations

  • Peking University Third Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Biological+Riluzole

Riluzole

Arm Description

Plasma from healthy young people treatment + Riluzole

Riluzole

Outcomes

Primary Outcome Measures

Amyotrophic lateral sclerosis Functional Rating Scale scores
Rate of amyotrophic lateral sclerosis Functional Rating Scale scores changes

Secondary Outcome Measures

Survival time
The time of the end event (death, tracheotomy, continuous ventilator dependence);
Forced vital capacity (FVC)
The change from baseline to the end of follow-up;
Cognitive function evaluation (ECAS score)
The change from baseline to the end of follow-up;

Full Information

First Posted
June 29, 2020
Last Updated
July 1, 2020
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04454840
Brief Title
Treatment of Intravenous Infusion Plasma in Amyotrophic Lateral Sclerosis
Official Title
A Clinical Study on Safety and Effectiveness of Intravenous Infusion Plasma From Healthy Young People to Treat Amyotrophic Lateral Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the safety and effectiveness of intravenous infusion of plasma from healthy young people for the treatment of amyotrophic lateral sclerosis.
Detailed Description
This is a single-center, open-label clinical study to evaluate the safety and effectiveness of intravenous infusion of plasma from healthy young people for the treatment of amyotrophic lateral sclerosis. The main outcome indicators are the record of adverse reactions and the rate of change of amyotrophic lateral sclerosisFunctional Rating Scale score. The secondary outcome indicators include survival time-time to the end event (death, tracheotomy, continuous ventilator dependence), forced vital capacity (FVC), recognition Knowledge function evaluation (ECAS score).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
Amyotrophic lateral sclerosis; Plasma infusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Open Lable
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biological+Riluzole
Arm Type
Experimental
Arm Description
Plasma from healthy young people treatment + Riluzole
Arm Title
Riluzole
Arm Type
Active Comparator
Arm Description
Riluzole
Intervention Type
Biological
Intervention Name(s)
Plasma from healthy young people treatment + Riluzole
Intervention Description
Intravenous injection: the subjects received 400ml of intravenous plasma infusion every 2 weeks, with a continuous course of 2 treatments and a course of treatment every 3 months. The course of treatment lasted 10 months, with a total of 3200ml of plasma infusion.
Intervention Type
Drug
Intervention Name(s)
Riluzole
Intervention Description
The basic treatment is Riluzole 25~50mg twice daily
Primary Outcome Measure Information:
Title
Amyotrophic lateral sclerosis Functional Rating Scale scores
Description
Rate of amyotrophic lateral sclerosis Functional Rating Scale scores changes
Time Frame
22 months after intervention
Secondary Outcome Measure Information:
Title
Survival time
Description
The time of the end event (death, tracheotomy, continuous ventilator dependence);
Time Frame
22 months after intervention
Title
Forced vital capacity (FVC)
Description
The change from baseline to the end of follow-up;
Time Frame
22 months after intervention
Title
Cognitive function evaluation (ECAS score)
Description
The change from baseline to the end of follow-up;
Time Frame
22 months after intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meet the following diagnosis standard: confirmed, proposed and laboratory supported diagnosis; Age 50-70 years old ; 3-18 months course of disease; Forced vital capacity (FVC) ≥70% predicted value; Total amyotrophic lateral sclerosis Functional Rating Scale score ≥36, scores of respiratory related items ≥10; Take Riluzole regularly before participate in this trial (25~50mg twice a day for at least 30 days continuously) without obvious side effects and can continue to take for 22 months; Participants of childbearing age take reasonable and effective contraceptive measures from the time of enrollment to the end of follow-up; Signed informed consent. Exclusion Criteria: Familial amyotrophic lateral sclerosis; Female during pregnancy and lactation; Positive hepatitis B, hepatitis C or HIV in screening History of cytomegalovirus and malaria infection; After tracheotomy and ventilator-dependent state (daily use of non-invasive ventilator ≥ 22 hours for 7 consecutive days); After percutaneous gastrostomy (PEG) operation; Has had allergic reactions and other adverse reactions during blood transfusion; Have diseases of the blood system (including Immunoglobulin A deficiency); alanine transaminase, Aspartate transaminase≥ 3 times the upper limit of normal; Abnormal renal function (Cr, BUN); History of malignant tumors; Combining severe cardiopulmonary diseases, autoimmune diseases, mental diseases, substance abuse history, etc; Currently participating in other clinical studies or using other drugs in researching.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dongsheng Fan, MD.PHD
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment of Intravenous Infusion Plasma in Amyotrophic Lateral Sclerosis

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