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Randomized, single-center Phase IV clinical trial of the efficacy and safety of human interferon alpha 2b suppository in the treatment of high-risk cervical human papillomavirus infection

Randomized, single-center Phase IV clinical trial of the efficacy and safety of human interferon alpha 2b suppository in the treatment of high-risk cervical human papillomavirus infection

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080044
Enrollment
Unknown
Registered
2024-01-18
Start date
2024-01-22
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-risk cervical human papillomavirus infection

Interventions

Group 1:Shuang Yinjie

Sponsors

Changshu City Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) HPV high-risk DNA test was positive; (2) Women between the ages of 20 and 60 who are married or have a sexual history; (3) no immune system diseases and major organ diseases; (4) Those who can persist in completing treatment; (5) Treatment without other anti-HPV drugs during the study period; (6) Voluntarily participate in this study and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Pregnant, lactating women or within 6 months after delivery; (2) Cervical pathology examination complicated with cervical intraepithelial neoplasia (including CIN I-III grade); (3) cervical cancer; (4) have a variety of vaginitis, or acute, subacute pelvic inflammation; (5) Allergic constitution, or known to be allergic to E. coli expression proteins or allergic to other components of the tested drug; (6) Complications such as chronic diseases of internal medicine and immune system diseases, neurological diseases, and other conditions that researchers believe that patients should not be included in this trial; (7) Have a history of serious drug abuse or alcohol abuse.

Design outcomes

Primary

MeasureTime frame
HPV negative conversion rate and overall response rate;

Secondary

MeasureTime frame
Adverse events during and 3 months after medication;Solicited adverse events: Adverse events that have been documented in the specification;Unsolicited adverse events: other adverse events;

Countries

China

Contacts

Public ContactZhao Na

Changshu City Hospital of Traditional Chinese Medicine

22540031@qq.com+86 138 1281 7430

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026