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Cervical Intraepithelial NeoplasiaPhase 2PGANCT01826045

Efficacy and Safety Study of PGA (Poly-gamma Glutamic Acid) for Cervical Intraepithelial Neoplasia

A Phase 2 study testing Poly-gamma Glutamic Acid in people with Cervical Intraepithelial Neoplasia, run by BioLeaders Corporation at 7 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

The purpose of this study is to determine the efficacy and the safety of PGA(Poly-gamma Glutamic Acid) for the the fertile women with Cervical Intraepithelial Neoplasia (CIN1). Read more about this study

Who is it for?
Ages 20 to 49 years, women only
Conditions the study is for
Cervical Intraepithelial Neoplasia
What is being tested?
Poly-gamma Glutamic Acid
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
7 sitesSouth Korea
Study dates
Jun 2013to Jan 2016
Phase
Phase 2
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 20 to 49 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Fertile women between age of 20 and 49
  • Patients with cervical intraepithelial neoplasia 1(CIN1)
  • HPV(Human Papilloma Virus) positive(+)
  • White Blood Cell Count(WBC) over 4thous/ul, Hemoglobin above over 9.0g/dL Platelet over 150thous/uL and ANC(Absolute Neutrophil Count) over 1,500 10^6/L
  • AST(Aspartate Aminotransferase) no less than 4 times higher than normal ALT(Alanine Aminotransferase) no less than 4 times higher than normal
  • Normal for EKG(Electrocardiography) and no active disease detected trough chest X-ray
  • Be informed of the nature of the study and will give written informed consent

Who cannot join

  • Malignant tumor in any organ other than cervical intraepithelial neoplasia
  • Active liver disease, immune disorder and severe renal failure
  • Leukemia, collagenosis, sclerosis, autoimmune disease, clinically significant allergic disease(mild allergic symptom not required medicine excluded)
  • Diagnosed diabetes
  • Taking any of followings affecting immunological reaction within 7 days (Glucocorticoid, vitamins, health food and oriental medicine etc)
  • Pregnancy and breastfeeding
  • Registered in other clinical trials
  • Patients whom the investigator considers inappropriate to participate in the study

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

South Korea7 sites

  • The Dongsan Medical Center of Keimyung Hospital

    Daegu, 700-712

  • Korea University Guro Hospital

    Seoul, Seoul, 152-703

  • Kwandong University College of Medicine Cheil Hospital

    Seoul, 100-380

  • CHA Gangnam Hospital

    Seoul, 135-913

  • The Catholic University, Korea Seoul St Mary's Hospital

    Seoul, 137-701

  • Korea University Guro Hospital

    Seoul, 152-703

  • MiZMedi Hospital

    Seoul, 157-723

Other trials in South Korea

About this study

Official title: A Multi-center, Randomized, Double Blind, Placebo Control, Parallel Design, Phase 2a Trial to Evaluate the Efficacy and Safety of PGA (Poly-gamma Glutamic Acid) for the Fertile Women With Cervical Intraepithelial Neoplasia 1 (CIN1)

The purpose of this study is to determine the efficacy and the safety of PGA(Poly-gamma Glutamic Acid) for the the fertile women with Cervical Intraepithelial Neoplasia (CIN1).

Read the detailed description

This study is to compare the regression rate of Cervical Intraepithelial Neoplasia (CIN1) between the treatment group and the control group.

The treatment group will be administered with PGA (Poly-gamma Glutamic Acid) for 4 weeks followed by 8 weeks observation.

The control group will be observed for 12 weeks without any comparator.

Being tested
Poly-gamma Glutamic Acid, Placebo
Keywords
Treatment of Cervical Intraepithelial Neoplasia(CIN1)
Medical subject headings
Uterine Cervical Dysplasia

What participants receive

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

  • Poly-gamma Glutamic AcidDrug

  • PlaceboDrug

Study groups in NCT01826045
Study groupRoleWhat they receive
Poly-gamma Glutamic AcidExperimentalPatients with cervical intraepithelial neoplasia 1(CIN1) will be administered Poly-gamma Glutamic Acid for 4 weeks.
Receives: Drug: Poly-gamma Glutamic Acid
PlaceboPlacebo comparatorPatients with cervical intraepithelial neoplasia 1(CIN1) will be administered placebo for 4 weeks.
Receives: Drug: Placebo

What is being measured

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

  1. Regression rate

    Regression rate will be assessed at the time of screening and 12 weeks. Regression means the change from the stage of CIN1 to normal.

    Measured: up to 12 weeks

Secondary outcomes (6)

  1. Reid Colposcopic Index

    Reid Colposcopic Index will be assessed at the time of screening and 12 weeks.

    Measured: up to 12 weeks

  2. Pap smear test

    Result of Pap smear test will be assessed at the time of screening and 12 weeks.

    Measured: up to 12 weeks

  3. HPV (Human Papilloma Virus) DNA Test

    Result of HPV (Human Papilloma Virus) DNA Test will be assessed at the time of screening and 12 weeks.

    Measured: up to 12 weeks

  4. HPV (Human Papilloma Virus) Hybrid CaptureII Test

    Result of HPV (Human Papilloma Virus) Hybrid CaptureII Test will be assessed at the time of screening and 12 weeks.

    Measured: up to 12 weeks

  5. NK (Natural Killer) Cell Activity

    Result of NK (Natural Killer) Cell Activity will be assessed at the time of baseline (0day), 4 weeks, 8 weeks and 12 weeks.

    Measured: up to 12 weeks

  6. Peripheral Blood Mononuclear Cells (PBMCs)Test

    Result of Peripheral Blood Mononuclear Cells (PBMCs) Test will be assessed at the time of baseline (0day), 4 weeks, 8 weeks and 12 weeks.

    Measured: up to 12 weeks

Timeline

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

  1. First posted8 Apr 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionDec 2015
  4. Study completionJan 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01826045
Sponsor's protocol ID
UMT2012-BL-PGA-01
Other IDs
12335
Acronym
PGA
Status last verified
Jan 2016
First submitted
29 Mar 2013
Last updated
29 Jan 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Cho HW, Park YC, Sung MH, Park JS, Kim TJ, Seong SJ, Cho CH, Lee JK. Short-term clinical and immunologic effects of poly-gamma-glutamic acid (gamma-PGA) in women with cervical intraepithelial neoplasia 1 (CIN 1): A multicenter, randomized, double blind, phase II trial. PLoS One. 2019 Jun 20;14(6):e0217745. doi: 10.1371/journal.pone.0217745. eCollection 2019.

    PubMed 31220105

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Poly-gamma Glutamic Acid in people with Cervical Intraepithelial Neoplasia, run by BioLeaders Corporation at 7 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 7 inclusion and 8 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 29 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Regression rate (time frame: up to 12 weeks). 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 NCT01826045, 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 29 Jan 2016.

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