Amyotrophic Lateral SclerosisEarly Phase 1NCT04454840

Treatment of Intravenous Infusion Plasma in Amyotrophic Lateral Sclerosis

A Early Phase 1 study testing Plasma from healthy young people treatment + Riluzole and Riluzole in people with Amyotrophic Lateral Sclerosis, run by Peking University Third Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the safety and effectiveness of intravenous infusion of plasma from healthy young people for the treatment of amyotrophic lateral sclerosis. Read more about this study

Who is it for?: Any age
Conditions the study is for: Amyotrophic Lateral Sclerosis
What is being tested?: Plasma from healthy young people treatment + Riluzole and Riluzole
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteChina
Study dates: 1 May 2016to 1 May 2019
Phase: Early Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

China1 site

Peking University Third Hospital
Beijing

Other trials in China

About this study

Official title: A Clinical Study on Safety and Effectiveness of Intravenous Infusion Plasma From Healthy Young People to Treat Amyotrophic Lateral Sclerosis

To evaluate the safety and effectiveness of intravenous infusion of plasma from healthy young people for the treatment of amyotrophic lateral sclerosis.

Read the 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).

Conditions: Amyotrophic Lateral Sclerosis
Being tested: Plasma from healthy young people treatment + Riluzole, Riluzole
Keywords: Amyotrophic lateral sclerosis; Plasma infusion
Medical subject headings: Amyotrophic Lateral Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Plasma from healthy young people treatment + RiluzoleBiological
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.
RiluzoleDrug
The basic treatment is Riluzole 25~50mg twice daily

Study groups in NCT04454840
Study group	Role	What they receive
Biological+Riluzole	Experimental	Plasma from healthy young people treatment + Riluzole Receives: Biological: Plasma from healthy young people treatment + Riluzole
Riluzole	Active comparator	Riluzole Receives: Drug: Riluzole

What is being measured

The primary outcome is the main question the study is designed to answer.

Amyotrophic lateral sclerosis Functional Rating Scale scores
Rate of amyotrophic lateral sclerosis Functional Rating Scale scores changes
Measured: 22 months after intervention

Secondary outcomes (3)

Survival time
The time of the end event (death, tracheotomy, continuous ventilator dependence);
Measured: 22 months after intervention
Forced vital capacity (FVC)
The change from baseline to the end of follow-up;
Measured: 22 months after intervention
Cognitive function evaluation (ECAS score)
The change from baseline to the end of follow-up;
Measured: 22 months after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 20161 May 2019

First posted2 Jul 2020
Study start1 May 2016
Primary completion1 May 2019
Study completion1 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
More trials run by Peking University Third HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04454840
Sponsor's protocol ID: PUTH2017118
Status last verified: Jul 2020
First submitted: 29 Jun 2020
Last updated: 7 Jul 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Amyotrophic Lateral Sclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Study on Safety and Effectiveness of Intravenous Infusion Plasma From Healthy Young People to Treat Amyotrophic Lateral Sclerosis
ClinicalTrials.gov ID: NCT04454840
Acronym / sponsor ID: PUTH2017118
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic lateral sclerosis; Plasma infusion
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Peking University Third HospitalUniversity, hospital or other
Study start: 1 May 2016 (actual)
Primary completion: 1 May 2019 (actual)
Study completion: 1 May 2019 (actual)
First posted: 2 Jul 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate the safety and effectiveness of intravenous infusion of plasma from healthy young people for the treatment of amyotrophic lateral sclerosis.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Biological+Riluzole	Experimental	Biological: Plasma from healthy young people treatment + RiluzolePlasma from healthy young people treatment + Riluzole
Riluzole	Active comparator	Drug: RiluzoleRiluzole

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (8 listed)

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;

Key exclusion criteria (13 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Plasma from healthy young people treatment + RiluzoleIntravenous 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.	Biological	Biological+Riluzole
RiluzoleThe basic treatment is Riluzole 25~50mg twice daily	Drug	Riluzole

Primary outcome

Amyotrophic lateral sclerosis Functional Rating Scale scores
Time frame: 22 months after intervention
Rate of amyotrophic lateral sclerosis Functional Rating Scale scores changes

3 secondary outcomes

Survival time
Time frame: 22 months after intervention
Forced vital capacity (FVC)
Time frame: 22 months after intervention
Cognitive function evaluation (ECAS score)
Time frame: 22 months after intervention

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
Individual participant dataSharing planned: No

Related trials for Amyotrophic Lateral Sclerosis

RecruitingPhase 1/2
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS
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A Study on the Addition of Alsum30 for the Treatment of Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS), Bacillus Coagulans
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
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Not yet recruitingPhase 1
Safety, Tolerability, and Pharmacodynamic Exploration of Orelabrutinib in Patients With Amyotrophic Lateral Sclerosis (ALS)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dongsheng Fan, MD.PHD principal investigator

Peking University Third Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amyotrophic lateral sclerosis Functional Rating Scale scores (time frame: 22 months after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04454840.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.