Interferon Alpha Therapy for Cervical CINI and HPV Infection

NCT06137950 | Completed Phase 1

• 1 other identifier: MNUMS2021100701
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Mongolia is a traditionally nomadic and population is scarce in rural areas. Thus, the medical care service is not sufficient. In 2000, Mongolian government has developed and implemented the millennium project in cooperation with WHO. During the years pap smear analysis of implemented in all rural areas and clinicians, lab technicians have been taught for the cervical cancer screening. However, the project has finished in 2015 and the rural and district hospitals has lost the trained professionals. Still the cervical cancer is in second place after liver cancer in women. The purpose of the study is to identify the type of HPV genotype and to treat the HPV infection by local interferon α2b. Materials and methods: HPV positive patients will be enrolled to the study. HPV genotype will be determined by the PCR in laboratory. Pap smear will be taken and staged by the CIN. Pathological tissue will be taken under colposcopy with acetic acid test. Follow up visit will be done on 10th, 30th days of the treatment. At the end of 90th days of treatment, pap and histology test will be repeated and CIN regression or viral eradication will be evaluated.

Conditions

Cervical Dysplasia; HPV Infection

Keywords

CIN I, HPV infection

Outcome Measures

Primary Outcomes (2)

• Pap smear

  LSIL, HSIL or regression of the change will be assessed.

  90 days

• Colposcopic change

  Cervical changes before and after treatment will be compared.

  90 days

Secondary Outcomes (2)

• Histopathologic change

  90 days

• Immunohistochemical change

  90 days

Study Arms (2)

Control

ACTIVE COMPARATOR

Interferon α2b gel treatment for 30 days.

Drug: gel Interferon arm

Treatment

EXPERIMENTAL

Interferon α2b gel treatment for 30 days \+ Interferon α2b 3 MIU rectal suppository for 10 days

Drug: gel Interferon arm; Drug: gel Interferon and interferon suppository arm

Interventions

gel Interferon arm DRUG

0.2 ml gel interferon will be administered into vaginal using 1 ml syringe with measurement line. Patients will be trained how to fill the syringe and put into the vagina. Gel will be administered 2 times per day during the non menstruating day totally for 28 days.

Also known as: Interferon alfa-2b low dose local treatment

Control; Treatment

gel Interferon and interferon suppository arm DRUG

0.2 ml gel interferon will be administered into vaginal using 1 ml syringe with measurement line. Patients will be trained how to fill the syringe and put into the vagina. Gel will be administered 2 times per day during the non menstruating day totally for 28 days. 3MIU suppository will be given to patients and will be trained how to use. Each patient in the arm will use the suppository twice a day for 10 days with vaginal therapy.

Also known as: Interferon alfa-2b low dose local and high dose systemic treatment

Treatment

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: This study is about treatment of uterine cervical dysplasia
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pap smear LSIL
• HPV infection positive
• No anti-viral treatment in 2 weeks before treatment

You may not qualify if:

• No consent has obtained
• Anti-viral treatment in 2 weeks
• Breastfeeding or pregnant

Sponsors & Collaborators

• Mongolian National University of Medical Sciences: lead
• Mongolian National Cancer Center: collaborator

Study Sites (1)

National Cancer Center

Ulaanbaatar, 17011, Mongolia

Location

Related Publications (4)

• Nestor MS, Gold MH, Kauvar AN, Taub AF, Geronemus RG, Ritvo EC, Goldman MP, Gilbert DJ, Richey DF, Alster TS, Anderson RR, Bank DE, Carruthers A, Carruthers J, Goldberg DJ, Hanke CW, Lowe NJ, Pariser DM, Rigel DS, Robins P, Spencer JM, Zelickson BD. The use of photodynamic therapy in dermatology: results of a consensus conference. J Drugs Dermatol. 2006 Feb;5(2):140-54.

  PMID: 16485882 BACKGROUND

• Hoffman SR, Le T, Lockhart A, Sanusi A, Dal Santo L, Davis M, McKinney DA, Brown M, Poole C, Willame C, Smith JS. Patterns of persistent HPV infection after treatment for cervical intraepithelial neoplasia (CIN): A systematic review. Int J Cancer. 2017 Jul 1;141(1):8-23. doi: 10.1002/ijc.30623. Epub 2017 Feb 27.

  PMID: 28124442 BACKGROUND

• Shi HJ, Song H, Zhao QY, Tao CX, Liu M, Zhu QQ. Efficacy and safety of combined high-dose interferon and red light therapy for the treatment of human papillomavirus and associated vaginitis and cervicitis: A prospective and randomized clinical study. Medicine (Baltimore). 2018 Sep;97(37):e12398. doi: 10.1097/MD.0000000000012398.

  PMID: 30213012 BACKGROUND

• Su Y, Zhang M, Zhang W, Shi H. Clinical efficacy of cryotherapy combined with interferon in the treatment of chronic cervicitis complicated with HPV infection. Pak J Pharm Sci. 2017 Jul;30(4(Suppl.)):1505-1508.

  PMID: 29044006 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Papillomavirus Infections

Interventions

Interferon alpha-2

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interferon-alpha; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Batsuren Choijamts, Ph.D

  Mongolian National University of Medical Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 18, 2023
• Study Start: November 7, 2023
• Primary Completion: November 15, 2024
• Study Completion: March 31, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)