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Immune ThrombocytopeniaPhase 3NCT02063789

An Open Phase 3 Study of IV-Globulin SN Inj.10% to Treat Immune Thrombocytopenia

A Phase 3 study testing Human immunoglobulin intravenous in people with Immune Thrombocytopenia, run by Green Cross Corporation at 14 sites in South Korea.

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

Human immunoglobulin (Ig) is the most commonly used blood product. It has been well-defined the efficacy in patients with immunodeficiencies, Kawasaki disease, asthma and other immune diseases. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Immune Thrombocytopenia
What is being tested?
Human immunoglobulin intravenous
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
14 sitesSouth Korea
Study dates
Jun 2014to Apr 2016
Phase
Phase 3
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Given written informed consent
  • Male or female aged ≥ 19
  • Primary immune thrombocytopenia (ITP)
  • Platelet <20x10^9 /L
  • Patients who have taken adrenal cortical hormones and/or other immunosuppressive medications should maintain their stable doses before and during this study

Who cannot join

  • Patients who have participate in other interventional study within 30 days
  • Inability in written/verbal communication
  • Engaged with an elective surgery
  • Pregnant or breast-feeding women
  • Women of childbearing potential who do not agree with contraception during this study
  • Patients who had experienced any hypersensitivity or shock with study drug or active ingredient
Show all 24Show fewer
  • Refractory to immunoglobulin therapy
  • Secondary immune thrombocytopenia
  • HIV-associated ITP
  • Lupus-associated ITP
  • Lymphproliferative disease
  • Hepatitis virus carrier
  • Other disease- or infection-associated ITP
  • Drug-Induced ITP
  • Hereditary thrombopenia (e.g., MYH9 disorders)
  • Hemolytic anemia (Positive direct Coomb's test)
  • Clinically significant abnormalities of immunoglobulin
  • Immunoglobulin A Deficiency
  • Immune disorders or deficiency
  • Alcohol or drug abuse within 6 months
  • Patients who had taken any medications which may effect platelet function or count for at least 2 days prior study entry
  • Patients who had administrated with IVIg or anti-D immunoglobulin agents within 1 month
  • Patients who had undergone a splenectomy within 2 months
  • Clinically significant underlying disease or medical history at investigator's discretion

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

South Korea14 sites

  • Chungnam National University Hospital

    Daejeon

  • Daegu Catholic University Medical Center

    Deagu

  • Chonnam National University Hwasun Hospital

    Hwasun

  • Gachon University Gil Medical Center

    Incheon

  • Chonbuk National University Hospital

    Jeonju

  • Pusan National University Hospital

    Pusan

  • Seoul National University Bundang Hospital

    Seongnam

  • Asan Medical Center

    Seoul

  • CHA Budang Medical Center

    Seoul

  • Ewha Womans University Medical Center

    Seoul

  • Samsung Medical Center

    Seoul

  • Severance Hospital

    Seoul

  • Soon Chung Hyang University Hospital

    Seoul

  • VHS Medical Center

    Seoul

Other trials in South Korea

About this study

Official title: Prospective, Non-Randomized, Open-label, Single-arm, Multi-Center Phase III Clinical Trial to Evaluate the Efficacy and Safety of IV-Globulin SN Inj.10% in the Patients Diagnosed With Immune Thrombocytopenia (ITP).

Human immunoglobulin (Ig) is the most commonly used blood product. It has been well-defined the efficacy in patients with immunodeficiencies, Kawasaki disease, asthma and other immune diseases. It is expected that Ig 10% will improve the usefulness and safety profile compared to Ig 5% because it is expected the reduced hospitalization/treatment duration and less adverse events related to volume overload.

Read the detailed description

GC5107A (IV-Globulin SN Inj. 10%) is a polyvalent intravenous human immunoglobulin G preparation. It is prepared from plasma collected from more than 1000 healthy blood donors and it expresses the large spectrum of antibody specificity.

Being tested
Human immunoglobulin intravenous
Keywords
Immune Thrombocytopenia, Immune Thrombocytopenic Purpura, Idiopathic Thrombocytopenic Purpura, Human Immunoglobulin, ITP, IVIg, IgIV, IV-Globulin SN Inj.
Medical subject headings
Purpura, Thrombocytopenic, Idiopathic

What participants receive

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

  • Human immunoglobulin intravenousDrug

    Also called GC5107A (IV-Globulin SN Inj. 10%)

    After GC5107A Intravenous injection, evaluate platelet increase

Study groups in NCT02063789
Study groupRoleWhat they receive
Human immunoglobulin intravenousExperimentalHuman immunoglobulin intravenous; GC5107A (IV-Globulin SN Inj. 10%); Day 1: GC5107A, 1g/kg, intravenous Day 2: GC5107A, 1g/kg, intravenous; Starting infusion rate: 0.01mg/kg/min (1mg/kg/min) for first 15 minutes, and then 2-fold increase every 30 minutes by maximum 0.08ml/kg/min (8mg/kg/min). Dosing modification is allowed due to tolerance.
Receives: Drug: Human immunoglobulin intravenous

What is being measured

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

  1. % of patients who achieved the platelet count ≥ 50 x 10^9/L increase

    Measured: within 7 days after intervention

Secondary outcomes (15)

  1. Duration from the achievement of platelet count ≥ 50 x 10^9/L increase to the loss

    Measured: 4 weeks after intervention

  2. % patient with response

    Response (R): platelet count ≥ 30 x 10^9/L and at least 2-fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart, and absence of bleeding.

    Measured: 4 weeks after intervention

  3. % patient with complete response

    Complete response (CR): platelet count >100 x 10^9/L, confirmed on at least 2 separate occasions at least 7 days apart, and absence of bleeding.

    Measured: 4 weeks after intervention

  4. Duration of response

    measured from the achievement of R to loss of R

    Measured: 4 weeks after intervention

  5. Duration of complete response

    measured from the achievement of CR to loss of CR

    Measured: 4 weeks after intervention

  6. % patient with no response

    No response (NR): platelet count < 30 x 10^9/l or less than 2-fold increase of baseline platelet count, confirmed on at least 2 separate occasions approximately 1 day apart, or bleeding.

    Measured: 4 weeks after intervention

  7. Descriptive statistics of platelet count at each visit

    Measured: 4 weeks after intervention

  8. Haemorrhage severity rate at each visit

    Haemorrhage severity score (HSS) system

    Measured: 4 weeks after intervention

  9. Quality of Life (EQ-5D)

    Measured: 4 weeks after intevention

  10. Patient reported bleeding events

    Measured: 12 weeks after intervention

  11. Usage of rescue mediations

    Rescue medications: Acetaminophen, antihistamines.

    Measured: 4 weeks after intervention

  12. Adverse events

    Measured: 12 weeks after intervention

  13. Drug compliance

    Measured: 2 days of intervention

  14. Viral safety

    Measured: Base line, 4 weeks and 12 weeks after intervention

  15. Time to the achievement of platelet count ≥50x10^9/L increase

    Measured: within 7 days after intervention

Timeline

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

  1. First posted14 Feb 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionApr 2016
  4. Study completionApr 2016

Resources

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02063789
Sponsor's protocol ID
GC5107A_P3
Status last verified
May 2016
First submitted
13 Feb 2014
Last updated
25 May 2016
Results posted
No
Data monitoring committee
No

Publications

  • Hong J, Bang SM, Mun YC, Yhim HY, Lee J, Lim HS, Oh D; Korean GC IVIg Investigators. Efficacy and Safety of a New 10% Intravenous Immunoglobulin Product in Patients with Primary Immune Thrombocytopenia (ITP). J Korean Med Sci. 2018 Apr 24;33(19):e142. doi: 10.3346/jkms.2018.33.e142. eCollection 2018 May 7.

    PubMed 29736158

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Human immunoglobulin intravenous in people with Immune Thrombocytopenia, run by Green Cross Corporation at 14 sites in South Korea.

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 5 inclusion and 24 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 25 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in South Korea. 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?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

% of patients who achieved the platelet count ≥ 50 x 10^9/L increase (time frame: within 7 days 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 NCT02063789, which also lists 1 linked publication.

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 25 May 2016.

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