NCT03158480

Brief Summary

Cytokine-induced killer (CIK) cells will be co-cultured with HPV induced dendritic cells (DCs); HPV specific DC-CIK will be induced to Condylomata Acuminata patients using interferon, whose recurrence rate and total cost will be compared to Condylomata Acuminata patients only use interferon.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 18, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

June 25, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

June 29, 2017

Status Verified

March 1, 2017

Enrollment Period

1.5 years

First QC Date

May 16, 2017

Last Update Submit

June 28, 2017

Conditions

Condylomata Acuminata

Keywords

DC-CIKinterferon

Outcome Measures

Primary Outcomes (1)

  • Condylomata Acuminata recurrence rate

    Condylomata Acuminata recurrence rate in 6 months after treatment

    6 months

Secondary Outcomes (2)

  • skin tissue HPV gene

    6 months

  • side effect

    6 months

Study Arms (2)

DC-CIK+interferon Group

EXPERIMENTAL

dendritic cell-activated cytokine-induced killer cells (DC-CIK) immunotherapy plus interferon intervention

Biological: DC-CIK immunotherapy

Placebo+interferon Group

PLACEBO COMPARATOR

saline as placebo plus interferon intervention

Biological: DC-CIK immunotherapy

Interventions

DC-CIK immunotherapyBIOLOGICAL

Cytokine-induced killer (CIK) cells are co-cultured with HPV induced dendritic cells (DCs); HPV specific DC-CIK will be induced to condylomata acuminata patients

DC-CIK+interferon GroupPlacebo+interferon Group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Second Hospital

Shenzhen, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Condylomata Acuminata

Condition Hierarchy (Ancestors)

Papillomavirus InfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesWartsSkin Diseases, ViralTumor Virus InfectionsGenital DiseasesUrogenital DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2017

First Posted

May 18, 2017

Study Start

June 25, 2017

Primary Completion

December 31, 2018

Study Completion

June 30, 2019

Last Updated

June 29, 2017

Record last verified: 2017-03

Locations

CN(1)