Guillain-Barre SyndromeNCT04550611
Mini-pool Intravenous Immunoglobulin (MP-IVIG) in Guillain-Barré Syndrome
A study testing Mini-pool Intravenous Immunoglobulin (MP-IVIG) and plasma exchange in people with Guillain-Barre Syndrome, run by Assiut University.
Trial summary
1. study the pharmacokinetics of mini-pooled intravenous immunoglobulin( MP-IVIG) 2. to determine the efficacy of intravenous immunoglobulin (IVIg) in hastening recovery and reducing the complications of Guillain-Barré syndrome (GBS). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Guillain-Barre Syndrome
- What is being tested?
- Mini-pool Intravenous Immunoglobulin (MP-IVIG) and plasma exchange
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2021to Dec 2022
- Phase
- Interventional
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age group: 18-40 years.
- Both sex are include
- The study will include patient diagnosed as Guillain-Barré syndrome (mild) cases in neuropsychiatric hospital at Assiut university hospitals.
Who cannot join
- • Patient has severe form of Guillain-Barré syndrome (GBS) according to GBS disability score
- Patient with renal impairment
- Patient with hepatic cell failure
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of Mini-pool Intravenous Immunoglobulin (MP-IVIG) Prepared by Assiut University Hospital Blood Bank in Guillain-Barré Syndrome
- study the pharmacokinetics of mini-pooled intravenous immunoglobulin( MP-IVIG)
- to determine the efficacy of intravenous immunoglobulin (IVIg) in hastening recovery and reducing the complications of Guillain-Barré syndrome (GBS).
- The MP-IVIG was tolerated and presented no safety issues in a previous study and we will be confirmed by monitoring any adverse events (anaphylaxis and haemolysis) ( no or mild or moderate) and reporting them to ethical committee safety monitoring group.
- Efficacy will be confirmed by:
- Patient able to walk
- Improvement of general health.
- Integration in to social live
- to compare the efficacy of IVIg to plasma exchange (PE) in hastening recovery and improving the condition of GBS
Read the detailed description
Guillain-Barré syndrome (GBS) is a frequent cause of neuromuscular paralysis occurring at all ages. The incidence of GBS is reported to be 1.2-2.3 per 100,000 per year .
GBS is a post infectious disorder. The most frequently identified preceding infection is Campylobacter jejuni. Others are cytomegalovirus, Epstein-Barr virus, Mycoplasma pneumoniae, and Haemophilus influenzae . Many reports have documented the occurrence of GBS shortly after vaccinations, operations, or stressful events, but the causality and pathophysiology are still debated .
Rapidly progressive weakness is the core clinical feature of GBS. By definition, maximal weakness is reached within 4 weeks, but most patients reach it within 2 to 3 weeks. Thereafter, patients enter a plateau phase that ranges from days to several weeks or months . This phase is followed by a usually much slower and variable recovery phase. In Europe, about one-third of GBS patients remain able to walk ("mild patients") .about 25% of the GBS patients who are unable to walk ("severe patients") need artificial ventilation. This is predominantly due to weakness of the respiratory muscles. GBS has a great impact on social life and the ability to perform activities of daily life. therefore, GBS remains a severe disease for which better treatments are required .
. Magdy EL-Ekiaby, et al 2010 introduce the concept of small-scale ("minipool") plasma processing methods. The preparation of the Immunoglobulin G (IgG) plasma fractionation from 20 blood donations which are tested for anti-A and anti-B titre < 32. Implementable with minimum infrastructural requirements. They developed viral inactivation and protein purification technologies in single-use equipment to prepare virally safe solvent/detergent-filtered (S/D-F) plasma Producing a 90%pure immunoglobulin fraction in disposable single-use devices for transfusion .
IVIG adverse events (AEs) are not frequent; hemolysis after IVIG is a known, rare complication. Higher doses and non-O blood group are key risk factors. The incidence of post-IVIG hemolysis is estimated at 1 per 1000 IVIG treatment episodes, most of which occur within 2 days of exposure. Although the preparation of blood group specific IVIGs in industry is a complex issue because of the pooling of thousands of plasma donations per batch, the preparation of blood group-specific mini-pool IVIG (MP-IVIG) is possible because each pool consists of only 20 plasma donations. Blood group-matched MP-IVIG is assumed to reduce the incidence of IVIG-associated hemolysis, which is largely caused by the presence of anti-A and anti-B agglutinins reacting with non-O blood group recipients.
- Conditions
- Guillain-Barre Syndrome
- Being tested
- Mini-pool Intravenous Immunoglobulin (MP-IVIG), plasma exchange
- Medical subject headings
- Guillain-Barre Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini-pool Intravenous Immunoglobulin (MP-IVIG)Other
The process of MP-IVIG preparation will involve the use of caprylic acid for purification and virus inactivation of Igs from mini-pools of 20 plasma donations collected in our CBTS in AUH. The equipment used for the process comprised disposable blood bags, hemodialyzers, and purification and microbial filters.
plasma exchangeOther
Also called plasmapheresis
plasma exchange (plasmapheresis ) in a regimen of removing of 1.3 plasma volumes in each cycle for total of five cycle for five consecutive days within four weeks of onset of symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Mini-pool Intravenous Immunoglobulin (MP-IVIG) | Experimental | will receive blood group -specific MP-IVIG in a regimen of 2 g/kg bodyweight, usually as 0.4 g/kg bodyweight per day for five consecutive days within two weak of onset of symptoms. Receives: Other: Mini-pool Intravenous Immunoglobulin (MP-IVIG) |
| plasmapheresis | Experimental | plasma exchange (plasmapheresis ) in a regimen of removing of 1.3 plasma volumes in each cycle for total of five cycle for five consecutive days within four weeks of onset of symptoms. Receives: Other: plasma exchange |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy ofMini-pool Intravenous Immunoglobulin (MP-IVIG) assessed by patients achieve score more than or equal 2 according to GBS disability score
Guillain-Barré syndrome disability scale Score Description 0 A healthy state
- Minor symptoms and capable of running
- Able to walk 10m or more without assistance but unable to run
- Able to walk 10m across an open space with help
- Bedridden or chairbound
- Requiring assisted ventilation for at least part of the day
- Dead
Measured: 6 MONTHS
Safety of MP-IVIG assessed by percentage of adverse Events: Overall percentage of adverse events
Overall percentage of adverse events as hemolysis and anaphylaxis headache and other complains that occur during 72 hours of following an infusion of MP-IVIG will be assessed by1) vital sign(pulse,blood pressure,Respiratory rate and temperature 2)Hemolysis by hemoglobin level, Lactate dehydrogenase( LDH),bilirubin level.2)between infusions by home diaries.
Measured: 72 hour after adminstration of MP-IVIG and between infusions period
Study the pharmacokinetics- MP-IVIG trough levels
MP-IVIG trough level concentration values of serum total IgG pre the MP-IVIG infusion (if applicable).
Measured: predose sample
Study the pharmacokinetics MP-IVIG plasma concentration -time curve [
Blood samples for analysis of pharmacokinetics MP-IVIG plasma concentration -time curve were obtained and analysed Blood samples for analysis of pharmacokinetics MP-IVIG plasma concentration -time curve were obtained and analysed
Measured: (1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days) post-dose ]
Study the pharmacokinetics MP-IVIG half-life
Blood samples for analysis of pharmacokinetics MP-IVIG haf-life were obtained and analysed
Measured: (1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days) post-dose ]
Study the pharmacokinetics MP-IVIG area under the curve
Blood samples for analysis of pharmacokinetics MP-IVIG haf-life were obtained and analysed
Measured: (1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days) post-dose ]
Study the pharmacokinetics MP-IVIG Cmax
Blood samples for analysis of pharmacokinetics MP-IVIG Cmax were obtained and analysed
Measured: (1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days) post-dose ]
Study the pharmacokinetics of MP-IVIG-Tmax.
Blood samples for analysis of pharmacokinetics MP-IVIG Tmax were obtained and analysed
Measured: (1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days) post-dose ]
Study the pharmacokinetics of MP-IVIG elimination rate constant(s). : (
Blood samples for analysis of pharmacokinetics MP-IVIG elimination rate constant(s) were obtained and analysed
Measured: 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days) post-dose ]
Secondary outcomes (1)
• compare the efficacy of IVIg to plasma exchange (PE) according to GBS disability score
Guillain-Barré syndrome disability scale Score Description 0 A healthy state
- Minor symptoms and capable of running
- Able to walk 10m or more without assistance but unable to run
- Able to walk 10m across an open space with help
- Bedridden or chairbound
- Requiring assisted ventilation for at least part of the day
- Dead
Measured: 6 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study startNov 2021 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Guillain-Barre SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The process of MP-IVIG preparation will involve the use of caprylic acid for purification and virus inactivation of Igs from mini-pools of 20 plasma donations collected in our Central blood transfusions( CBTS) in Assiut University Hospital (AUH). The equipment used for the process comprised disposable blood bags, hemodialyzers, and purification and microbial filters.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Ahmed Hassan Moubark, Assiut University
- Investigators
- Maha A Mohamed, Prof, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550611
- Sponsor's protocol ID
- Guillain-Barré syndrome
- Status last verified
- Sep 2020
- First submitted
- 27 Aug 2020
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
van Doorn PA, Ruts L, Jacobs BC. Clinical features, pathogenesis, and treatment of Guillain-Barre syndrome. Lancet Neurol. 2008 Oct;7(10):939-50. doi: 10.1016/S1474-4422(08)70215-1.
PubMed 18848313El-Ekiaby M, Vargas M, Sayed M, Gorgy G, Goubran H, Radosevic M, Burnouf T. Minipool caprylic acid fractionation of plasma using disposable equipment: a practical method to enhance immunoglobulin supply in developing countries. PLoS Negl Trop Dis. 2015 Feb 26;9(2):e0003501. doi: 10.1371/journal.pntd.0003501. eCollection 2015 Feb.
PubMed 25719558El-Ekiaby M, Sayed MA, Caron C, Burnouf S, El-Sharkawy N, Goubran H, Radosevich M, Goudemand J, Blum D, de Melo L, Soulie V, Adam J, Burnouf T. Solvent-detergent filtered (S/D-F) fresh frozen plasma and cryoprecipitate minipools prepared in a newly designed integral disposable processing bag system. Transfus Med. 2010 Feb;20(1):48-61. doi: 10.1111/j.1365-3148.2009.00963.x. Epub 2009 Sep 23.
PubMed 19778318Winiecki S, Baer B, Chege W, Jankosky C, Mintz P, Baker M, Woodworth T, Nguyen M. Complementary use of passive surveillance and Mini-Sentinel to better characterize hemolysis after immune globulin. Transfusion. 2015 Jul;55 Suppl 2:S28-35. doi: 10.1111/trf.13116.
PubMed 26174895Ojha R, Karn R(2019):Clinical outcome of intravenous immunoglobulin in the treatment of Guillain Barre Syndrome in a Nepalese tertiary centre. Nep Med J 2019;2(1):133-7.
Hughes RA, Cornblath DR. Guillain-Barre syndrome. Lancet. 2005 Nov 5;366(9497):1653-66. doi: 10.1016/S0140-6736(05)67665-9.
PubMed 16271648
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Mini-pool Intravenous Immunoglobulin (MP-IVIG) Prepared by Assiut University Hospital Blood Bank in Guillain-Barré Syndrome
- ClinicalTrials.gov ID
- NCT04550611
- Acronym / sponsor ID
- Guillain-Barré syndrome
- Conditions
- Guillain-Barre Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 16 Sep 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.
- study the pharmacokinetics of mini-pooled intravenous immunoglobulin( MP-IVIG)
- to determine the efficacy of intravenous immunoglobulin (IVIg) in hastening recovery and reducing the complications of Guillain-Barré syndrome (GBS).
- The MP-IVIG was tolerated and presented no safety issues in a previous study and we will be confirmed by monitoring any adverse events (anaphylaxis and haemolysis) ( no or mild or moderate) and reporting them to ethical committee safety monitoring group.
- Efficacy will be confirmed by:
- Patient able to walk
- Improvement of general health.
- Integration in to social live
- to compare the efficacy of IVIg to plasma exchange (PE) in hastening recovery and improving the condition of GBS
Detailed description
Guillain-Barré syndrome (GBS) is a frequent cause of neuromuscular paralysis occurring at all ages. The incidence of GBS is reported to be 1.2-2.3 per 100,000 per year .
GBS is a post infectious disorder. The most frequently identified preceding infection is Campylobacter jejuni. Others are cytomegalovirus, Epstein-Barr virus, Mycoplasma pneumoniae, and Haemophilus influenzae . Many reports have documented the occurrence of GBS shortly after vaccinations, operations, or stressful events, but the causality and pathophysiology are still debated .
Rapidly progressive weakness is the core clinical feature of GBS. By definition, maximal weakness is reached within 4 weeks, but most patients reach it within 2 to 3 weeks. Thereafter, patients enter a plateau phase that ranges from days to several weeks or months . This phase is followed by a usually much slower and variable recovery phase. In Europe, about one-third of GBS patients remain able to walk ("mild patients") .about 25% of the GBS patients who are unable to walk ("severe patients") need artificial ventilation. This is predominantly due to weakness of the respiratory muscles. GBS has a great impact on social life and the ability to perform activities of daily life. therefore, GBS remains a severe disease for which better treatments are required .
. Magdy EL-Ekiaby, et al 2010 introduce the concept of small-scale ("minipool") plasma processing methods. The preparation of the Immunoglobulin G (IgG) plasma fractionation from 20 blood donations which are tested for anti-A and anti-B titre < 32. Implementable with minimum infrastructural requirements. They developed viral inactivation and protein purification technologies in single-use equipment to prepare virally safe solvent/detergent-filtered (S/D-F) plasma Producing a 90%pure immunoglobulin fraction in disposable single-use devices for transfusion .
IVIG adverse events (AEs) are not frequent; hemolysis after IVIG is a known, rare complication. Higher doses and non-O blood group are key risk factors. The incidence of post-IVIG hemolysis is estimated at 1 per 1000 IVIG treatment episodes, most of which occur within 2 days of exposure. Although the preparation of blood group specific IVIGs in industry is a complex issue because of the pooling of thousands of plasma donations per batch, the preparation of blood group-specific mini-pool IVIG (MP-IVIG) is possible because each pool consists of only 20 plasma donations. Blood group-matched MP-IVIG is assumed to reduce the incidence of IVIG-associated hemolysis, which is largely caused by the presence of anti-A and anti-B agglutinins reacting with non-O blood group recipients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The process of MP-IVIG preparation will involve the use of caprylic acid for purification and virus inactivation of Igs from mini-pools of 20 plasma donations collected in our Central blood transfusions( CBTS) in Assiut University Hospital (AUH). The equipment used for the process comprised disposable blood bags, hemodialyzers, and purification and microbial filters.
| Arm | Type | Receives |
|---|---|---|
| Mini-pool Intravenous Immunoglobulin (MP-IVIG) | Experimental | Other: Mini-pool Intravenous Immunoglobulin (MP-IVIG)will receive blood group -specific MP-IVIG in a regimen of 2 g/kg bodyweight, usually as 0.4 g/kg bodyweight per day for five consecutive days within two weak of onset of symptoms. |
| plasmapheresis | Experimental | Other: plasma exchangeplasma exchange (plasmapheresis ) in a regimen of removing of 1.3 plasma volumes in each cycle for total of five cycle for five consecutive days within four weeks of onset of symptoms. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age group: 18-40 years.
- Both sex are include
- The study will include patient diagnosed as Guillain-Barré syndrome (mild) cases in neuropsychiatric hospital at Assiut university hospitals.
Key exclusion criteria (3 listed)
- • Patient has severe form of Guillain-Barré syndrome (GBS) according to GBS disability score
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 |
|---|---|---|
| Mini-pool Intravenous Immunoglobulin (MP-IVIG)The process of MP-IVIG preparation will involve the use of caprylic acid for purification and virus inactivation of Igs from mini-pools of 20 plasma donations collected in our CBTS in AUH. The equipment used for the process comprised disposable blood bags, hemodialyzers, and purification and microbial filters. | Other | Mini-pool Intravenous Immunoglobulin (MP-IVIG) |
| plasma exchangeAlso: plasmapheresisplasma exchange (plasmapheresis ) in a regimen of removing of 1.3 plasma volumes in each cycle for total of five cycle for five consecutive days within four weeks of onset of symptoms. | Other | plasmapheresis |
Primary outcome
Efficacy ofMini-pool Intravenous Immunoglobulin (MP-IVIG) assessed by patients achieve score more than or equal 2 according to GBS disability score
Time frame: 6 MONTHS
Guillain-Barré syndrome disability scale Score Description 0 A healthy state 1. Minor symptoms and capable of running 2. Able to walk 10m or more without assistance but unable to run 3. Able to walk 10m across an open space with help 4. Bedridden or chairbound 5. Requiring assisted ventilation for at least part of the day 6. Dead
Safety of MP-IVIG assessed by percentage of adverse Events: Overall percentage of adverse events
Time frame: 72 hour after adminstration of MP-IVIG and between infusions period
Overall percentage of adverse events as hemolysis and anaphylaxis headache and other complains that occur during 72 hours of following an infusion of MP-IVIG will be assessed by1) vital sign(pulse,blood pressure,Respiratory rate and temperature 2)Hemolysis by hemoglobin level, Lactate dehydrogenase( LDH),bilirubin level.2)between infusions by home diaries.
Study the pharmacokinetics- MP-IVIG trough levels
Time frame: predose sample
MP-IVIG trough level concentration values of serum total IgG pre the MP-IVIG infusion (if applicable).
Study the pharmacokinetics MP-IVIG plasma concentration -time curve [
Time frame: (1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days) post-dose ]
Blood samples for analysis of pharmacokinetics MP-IVIG plasma concentration -time curve were obtained and analysed Blood samples for analysis of pharmacokinetics MP-IVIG plasma concentration -time curve were obtained and analysed
Study the pharmacokinetics MP-IVIG half-life
Time frame: (1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days) post-dose ]
Blood samples for analysis of pharmacokinetics MP-IVIG haf-life were obtained and analysed
Study the pharmacokinetics MP-IVIG area under the curve
Time frame: (1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days) post-dose ]
Blood samples for analysis of pharmacokinetics MP-IVIG haf-life were obtained and analysed
Study the pharmacokinetics MP-IVIG Cmax
Time frame: (1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days) post-dose ]
Blood samples for analysis of pharmacokinetics MP-IVIG Cmax were obtained and analysed
Study the pharmacokinetics of MP-IVIG-Tmax.
Time frame: (1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days) post-dose ]
Blood samples for analysis of pharmacokinetics MP-IVIG Tmax were obtained and analysed
Study the pharmacokinetics of MP-IVIG elimination rate constant(s). : (
Time frame: 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days) post-dose ]
Blood samples for analysis of pharmacokinetics MP-IVIG elimination rate constant(s) were obtained and analysed
1 secondary outcome
• compare the efficacy of IVIg to plasma exchange (PE) according to GBS disability score
Time frame: 6 MONTHS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Background: PubMed 18848313van Doorn PA, Ruts L, Jacobs BC. Clinical features, pathogenesis, and treatment of Guillain-Barre syndrome. Lancet Neurol. 2008 Oct;7(10):939-50. doi: 10.1016/S1474-4422(08)70215-1.
- Background: PubMed 25719558El-Ekiaby M, Vargas M, Sayed M, Gorgy G, Goubran H, Radosevic M, Burnouf T. Minipool caprylic acid fractionation of plasma using disposable equipment: a practical method to enhance immunoglobulin supply in developing countries. PLoS Negl Trop Dis. 2015 Feb 26;9(2):e0003501. doi: 10.1371/journal.pntd.0003501. eCollection 2015 Feb.
- Background: PubMed 19778318El-Ekiaby M, Sayed MA, Caron C, Burnouf S, El-Sharkawy N, Goubran H, Radosevich M, Goudemand J, Blum D, de Melo L, Soulie V, Adam J, Burnouf T. Solvent-detergent filtered (S/D-F) fresh frozen plasma and cryoprecipitate minipools prepared in a newly designed integral disposable processing bag system. Transfus Med. 2010 Feb;20(1):48-61. doi: 10.1111/j.1365-3148.2009.00963.x. Epub 2009 Sep 23.
- Background: PubMed 26174895Winiecki S, Baer B, Chege W, Jankosky C, Mintz P, Baker M, Woodworth T, Nguyen M. Complementary use of passive surveillance and Mini-Sentinel to better characterize hemolysis after immune globulin. Transfusion. 2015 Jul;55 Suppl 2:S28-35. doi: 10.1111/trf.13116.
- BackgroundOjha R, Karn R(2019):Clinical outcome of intravenous immunoglobulin in the treatment of Guillain Barre Syndrome in a Nepalese tertiary centre. Nep Med J 2019;2(1):133-7.
- Results publication: PubMed 16271648Hughes RA, Cornblath DR. Guillain-Barre syndrome. Lancet. 2005 Nov 5;366(9497):1653-66. doi: 10.1016/S0140-6736(05)67665-9.
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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.
Maha A Mohamed, Prof study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Mini-pool Intravenous Immunoglobulin (MP-IVIG) and plasma exchange in people with Guillain-Barre Syndrome, run by Assiut University.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hend A Moubark, Specialist (01010326577, hindq1989@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy ofMini-pool Intravenous Immunoglobulin (MP-IVIG) assessed by patients achieve score more than or equal 2 according to GBS disability score (time frame: 6 MONTHS). The study lists 9 primary outcomes in all. 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 NCT04550611, which also lists 6 linked publications.
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 14 Jan 2021.